BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, RASP, DISTAL, CURVED, 16/140

    MDR report key: 7068571 · Received November 29, 2017

    Report

    Report Number
    0009613350-2017-01683
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 6, 2017
    Report Date
    April 9, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HTR
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: REVITAN, RASP ADAPTER WITH LENGTH MARKINGS ITEM#: 01.00409.501 LOT#: 14.948010. REVITAN, RASP, DISTAL, CURVED, 16/200 ITEM#: 01.00409.623 LOT#: 15.142877. REVITAN, RASP, DISTAL, CURVED, 14/140 ITEM#: 01.00409.612 LOT#: 15.142869. REVITAN RASP DISTAL CURVED 14/140 REF: 01.00409.612, LOT: 15.142869. REVITAN RASP DISTAL CURVED 16/200 REF: 01.00409.623, LOT: 15.142877. REVITAN RASP DISTAL CURVED 16/140 REF: 01.00409.613, LOT: 14.095943. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND IDENTIFIED. REPORTED EVENT: INCIDENT OCCURRED DURING IMPLANTATION OF A REVITAN STEM. X-RAY CONTROL REVEALED THE POSSIBILITY OF RASP UP TO SIZE 16. THE RASP 16/200, CONTRARY TO EXPECTATIONS, COULD NOT BE REMOVED FROM THE FEMUR. WHEN TRYING TO REMOVE THE RASP 16/200, THE HANDLE OF THE INSTRUMENT "REVITAN RASP ADAPTER" REF: 01.00409.501, BROKE OFF. AFTER THE CROSSBAR FELL ON THE GROUND DURING MANIPULATION, THE RASP 14/140 WAS USED AS AN ABUTMENT / CROSSBAR AND THEREBY GOT DAMAGED. ONLY AFTER EXTENSIVE FENESTRATION OF THE FEMUR, THE RASP 16/200 COULD BE REMOVED. IMPLANTATION OF A REVITAN DISTALLY 16/200 AND A REVITAN 16/260 FAILED, AS THE IMPLANTS DID NOT FIND PROPER SUPPORT IN THE BONE. FINALLY, IMPLANTATION OF A WEBER SHAFT S-L WITH VARIOUS ADDITIONAL CERCLAGES. REVIEW OF RECEIVED DATA: FOUR INTRAOPERATIVE IMAGES HAVE BEEN RECEIVED, SHOWING THE USED INSTRUMENTS. IT IS VISIBLE THAT THE RASP ADAPTER HAS BROKEN OFF. A SURGICAL REPORT FROM 6 NOV 2017 HAS BEEN RECEIVED. IT IS MENTIONED THAT A PREOPERATIVE MEDICAD-PLANNING HAS BEEN PERFORMED. THE FEMUR WAS RASPED TO SIZE 14, HOWEVER, THE REVITAN TRIAL STEM SIZE 140MM WAS FOUND TO BE TOO SHORT. ADDITIONALLY NO GOOD BONE SUPPORT. TRIAL SIZE 16X200MM FOUND GOOD BONE SUPPORT. IT IS MENTIONED THAT THE FENESTRATION WOULD BE WELL BRIDGED. HOWEVER, TRIAL (RASP) COULD NOT BE REMOVED ANYMORE. TRYING TO DO SO, THE END OF THE RASP ADAPTER WAS BROKEN OFF WITH HAMMER BLOWS. THE FENESTRATION WAS REOPENED, EXTENDED DISTALLY AND FINALLY ALSO PROXIMALLY. EVENTUALLY TRIAL (RASP) COULD BE REMOVED. REVITAN STEM WAS IMPLANTED, HOWEVER IT DID NOT FIND PROPER BONE SUPPORT. ANOTHER FENESTRATION HAS BEEN NECESSARY FOR ITS REMOVAL. ALSO IMPLANTATION OF STEM 16/200 IN COMBINATION WITH A 85MM NECK FAILED. IMPLANTATION OF A WEBER S-L STEM PERFORMED. SEVERAL X-RAYS HAVE BEEN RECEIVED. FOUR OF THEM DISPLAY THE PATIENT'S SPINE AND ARE THEREFORE IRRELEVANT FOR THIS INVESTIGATION. THREE POST OPERATIVE (REVISION) X-RAYS DATED 08 NOV 2017 HAVE BEEN RECEIVED, SHOWING THE IMPLANTED WAGNER STEM. ONE X-RAY SHOWING THE PREOPERATIVE PLANNING DATED ON 17 OCT 2017 HAS BEEN RECEIVED. AS A STEM, THE REVITAN DISTAL CURVED SIZE 14/200 (REF 01.00406.214) HAS BEEN CHOSEN. HOWEVER, AS MENTIONED IN THE SURGICAL TECHNIQUE, THE STEM SIZE 14 DID NOT FIND GOOD BONE SUPPORT, THEREFORE THE SURGEON HAD TO RASP TO SIZE 16. DEVICES ANALYSIS VISUAL EXAMINATION: REVITAN RASP ADAPTER (REF: 01.00409.501): THE STRIKING PLATE OF THE INSTRUMENT BROKE OFF (THE LOCATION OF THE FRACTURE IS IN THE MIDDLE OF THE CROSS-HOLE NEXT TO THE STRIKING PLATE). THE ADAPTER SHOWS MULTIPLE DENTS AND SCRATCHES IN THE AREA OF THE CROSS-HOLES. ADDITIONALLY, THE DISTAL PART OF THE NOTCH SHOWS CLEAR SIGNS OF DEFORMATION CAUSED BY ABNORMAL FORCES. FURTHERMORE, SCRATCHES ARE FOUND IN THE PROXIMAL PART OF THE ADAPTER. -REVITAN RASP DISTAL CURVED 16/200 (REF: 01.00409.623): THE RASP SHOWS CLEAR SIGNS OF DEFORMATION OF THE TEETHS IN THE MIDDLE OF THE RASP AREA. FURTHERMORE, THE CONNECTOR BUTTON IS DEFORMED AND SHOWS SIGNS OF AN INCLINED APPLICATION OF FORCE. IN ADDITION, THE TIP OF THE RASP SHOWS SIGNS OF DEFORMATION, MOST LIKELY CAUSED BY HITTING THE TIP WITH ANOTHER INSTRUMENT. REVITAN RASP DISTAL CURVED 14/140 (REF: 01.00409.612): THE RASP SHOWS CLEAR SIGNS OF DEFORMATION OF THE TEETHS IN THE MIDDLE OF THE RASP AREA. REVITAN RASP DISTAL CURVED 16/140 (REF: 01.00409.613): THE RASP SHOWS LIGHT SIGNS OF DEFORMATION OF THE TEETHS IN THE DISTAL PART OF THE RASP AREA. REVITAN MODULAR DISTAL CURVED 16/200 (REF: 01.00406.216) CONNECTED TO THE REVITAN PROX. CYLINDRICAL (REF: 01.00402.095): THE REVITAL MODULAR DISTAL CURVED IMPLANT SHOWS SCRATCHES NEXT TO THE CONNECTION TO THE REVITAL PROX. CYLINDRICAL IMPLANT. IN ADDITION, THE TIP OF THE REVITAL MODULAR DISTAL CURVED IMPLANT SHOWS SIGNS OF DEFORMATION, MOST LIKELY CAUSED BY HITTING THE TIP WITH ANOTHER INSTRUMENT. REVITAL PROX. CYLINDRICAL IMPLANT SHOWS NORMAL SIGNS OF USAGE. REVITAN DISTAL CURVED 16/260 (REF: 01.00406.316): THE IMPLANT SHOWS NO CONSIDERABLE DAMAGE. MEASUREMENTS: MEASUREMENTS WERE PERFORMED ON THE REVITAN RASP ADAPTER AND THE REVITAN RASP 16/200 ONLY, AS THESE DEVICES WERE CAUSING THE ISSUE. ALL OTHER DEVICES WERE DAMAGED DURING THE FOLLOWING PROBLEM SOLVING. FOR THE RASP ADAPTER: TO ENSURE THE FRACTURED REVITAN ADAPTER (REF: 01.00409.501) HAS CORRECT DIMENSIONS, RELEVANT CHARACTERISTICS ACCORDING TO THE CORRESPONDING INSPECTION PLAN WERE MEASURED WITH THE CALIPER. INSPECTION PLAN: CHARACTERISTIC NO. 37 FEATURE ¿DIAMETER (12.2 +0.15/0) MM¿: SPECIFICATION: MAX. 12.35 MM; MIN. 12.2 MM, MEASURED VALUE: 12.25 MM CONCLUSION: THE SIZE OF THE CROSS-HOLE CAN BE CONFIRMED (BASED ON THE INNER DIAMETER). CHARACTERISTIC NO. 4 FEATURE ¿DIAMETER (18 +0.2/-0.2) MM¿: SPECIFICATION: MAX. 18.2 MM; MIN. 17.8 MM, MEASURED VALUE: 18.03 MM CONCLUSION: THE SIZE OF THE OUTER DIAMETER CAN BE CONFIRMED. FOR THE RASP 16/200: INSPECTION PLAN AND PRODUCT DRAWING: CHARACTERISTIC NO. 7 FEATURE ¿OUTER DIAMETER CUT A-A (18.44 +0.2/-0.2) MM¿: SPECIFICATION: MAX. 18.64 MM; MIN. 18.24 MM, MEASURED VALUE: 18.41 MM CHARACTERISTIC NO. 7 FEATURE ¿OUTER DIAMETER CUT B-B (16.04 +0.2/-0.2) MM¿: SPECIFICATION: MAX. 16.24 MM; MIN. 15.84 MM, MEASURED VALUE: 16.04 MM CHARACTERISTIC NO. 8 FEATURE ¿DIMENSION CUT C-C (15.27 +0.2/-0.2) MM¿: SPECIFICATION: MAX. 15.47 MM; MIN. 15.07 MM, MEASURED VALUE: 15.39 MM CHARACTERISTIC NO. 8 FEATURE ¿DIMENSION CUT C-C (13.86 +0.2/-0.2) MM¿: SPECIFICATION: MAX. 14.06 MM; MIN. 13.66 MM, MEASURED VALUE: 14.06 MM CONCLUSION: EVEN THOUGH, THE PART SHOWS DAMAGES, THE SIZE OF THE OUTER DIAMETERS CAN BE CONFIRMED FURTHER THE DHR INDICATES THAT ALL COMPONENTS MET ALL SPECIFICATIONS. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. INSPECTION PLANNING: INSPECTION PLANS FOR ARTICLES DIRECTLY RELATED TO THE REPORTED ISSUE (RASP ADAPTER AND RASP 16/200 WHICH GOT STUCK) ARE CONSIDERED. DAMAGE TO ALL OTHER ARTICLES FOLLOWED DURING PROBLEM SOLVING. RETURNED STEMS ARE CONSIDERED AS ASSOCIATED DEVICES. REVITAN RASP ADAPTER (REF: 01.00409.501): INSPECTION PLAN: CHARACTERISTIC NO. 7 FEATURE, ¿MATERIAL 1.4021". SCOPE OF TESTING: 100% CHARACTERISTIC NO. 36 FEATURE, "DIAMETER ( 12.2 0.15/0 ) MM". SCOPE OF TESTING: AQL 2.5 CHARACTERISTIC NO. 4 FEATURE, ¿DIAMETER (18 +/- 0.2)". SCOPE OF TESTING: FAL REVITAN RASP DISTAL CURVED 16/200 (REF: 01.00409.623): INSPECTION PLAN: CHARACTERISTIC NO. 7 FEATURE ¿OUTER CROSS-SECTIONAL DIAMETER OF CUT A-A , B-B" WITH SCOPE OF TESTING 100%. MEANS OF INSPECTION: CALIPER. CHARACTERISTIC NO. 8 FEATURE ¿OUTER CROSS-SECTIONAL DIMENSION OF CUT C-C , D-D , E-E" WITH SCOPE OF TESTING 100%. MEANS OF INSPECTION:CALIPER. ROOT CAUSE ANALYSIS; ROOT CAUSE DETERMINATION USING RMW FOR THE REVITAN RASP ADAPTER (REF: 01.00409.501): LINE R-1.4.8: INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE -> NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LINE R-1.4.15: INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT -> NOT POSSIBLE ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION THE MATERIAL HAS BEEN TESTED. FURTHER A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LINE R-2.2.2: FRACTURE OF INSTRUMENT DUE TO GENERAL CORROSION (CREVICE, PITTING, GALVANIC) -> NOT POSSIBLE. VISUAL EXAMINATION OF THE INSTRUMENT DOES NOT REVEAL ANY SIGNS OF CORROSION. LINE R-3.1.2: INSTRUMENT CANNOT BE USED WITH THE MATING INSTRUMENT OR MATING IMPLANT AS INTENDED DUE TO FAILURE OF INSTRUMENT MATING CONDITION => POSSIBLE, AS THE STRIKING PLATE BROKE OFF, THE INSTRUMENT CANNOT BE USED WITH MATING INSTRUMENTS AS INTENDED. LINE R-3.1.8: DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE. THE SURGEON'S INSTRUMENT HANDLING WAS ACCORDING TO SURGICAL TECHNIQUE UNTIL RASP COULD NOT BE REMOVED FROM THE FEMUR AND THE STRIKING PLATE OF THE REVITAN ADAPTER BROKE OFF. NEVERTHELESS, THE DEFORMATION OF THE RASP CONNECTOR TIP INDICATES THAT THE SURGEON USED THE ADAPTER WITHOUT CLOSING THE COVER TO SECURE THE CONNECTION OF THE RASP AND THE ADAPTER. FURTHERMORE, THE DAMAGE OF THE CONNECTOR TIP OF THE RASP REVEALS THAT THE RASP AND THE ADAPTER WERE NOT ALIGNED PROPERLY. IN ADDITION, THE NOTCH OF THE ADAPTER SHOWS DEFORMATION DUE TO ABNORMAL FORCES. LINE R-3.2.2: DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING -> NOT POSSIBLE. THE SURGEON'S INSTRUMENT HANDLING WAS ACCORDING TO SURGICAL TECHNIQUE UNTIL RASP COULD NOT BE REMOVED FROM THE FEMUR AND THE STRIKING PLATE OF THE REVITAN ADAPTER BROKE OFF. LINE R-3.2.9: INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE => POSSIBLE, AS ABNORMAL HIGH FORCES WERE APPLIED ON THE ADAPTER AFTER THE RASP GOT STUCK IN THE FEMUR. FURTHER, AN ADDITIONAL REVITAN RASP WAS USED AS CROSS BAR, AFTER THE ORIGINAL CROSS BAR HAD FALLEN TO THE GROUND. THEN, THE SURGEON HIT WITH AN ADDITIONAL INSTRUMENT ON THE DISTAL PART OF THE NOTCH, IN ORDER TO REMOVE THE ADAPTER WITH THE RASP FROM THE FEMUR, AFTER THE STRIKING PLATE OF THE ADAPTER HAD BROKEN OFF. LINE R-3.2.14: INSTRUMENT CANNOT BE USED WITH THE CONNECTED INSTRUMENT AS INTENDED DUE TO FAILURE OF INSTRUMENT ASSEMBLY CONDITION =>POSSIBLE, AS THE STRIKING PLATE BROKE OFF, THE INSTRUMENT CANNOT BE USED WITH MATING INSTRUMENTS AS INTENDED. ROOT CAUSE DETERMINATION USING RMW FOR THE REVITAN RASP 16/200 (REF: 01.00409.623): LINE R-1.4.1: INSTRUMENT, BREAKS, DEFORMS, DIVERGE, OR PARTS REMAIN IN WOUND. DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE -> NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LINE R-1.4.8: INSTRUMENT, BREAKS, DEFORMS, DIVERGE, OR PARTS REMAIN IN WOUND. DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT -> NOT POSSIBLE ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION THE MATERIAL HAS BEEN TESTED. FURTHER A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LINE R-3.1.2: INSTRUMENT CANNOT BE USED WITH THE MATING INSTRUMENT OR MATING IMPLANT AS INTENDED DUE TO FAILURE OF INSTRUMENT MATING CONDITION => POSSIBLE, DUE TO THE DEFORMATION OF THE CONNECTOR PIN AND BUTTON OF THE RASP, THE REVITAN ADAPTER CANNOT BE CONNECTED. LINE R-3.1.9: DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING -> NOT POSSIBLE. EVEN THOUGH THE RASP GOT STUCK IN THE FEMUR, NOTHING INDICATES THAT THE SURGEON WAS UNFAMILIAR WITH THE INSTRUMENT USAGE / HANDLING. LINE R-3.2.2: DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING -> NOT POSSIBLE. EVEN THOUGH THE RASP GOT STUCK IN THE FEMUR, NOTHING INDICATES THAT THE SURGEON WAS UNFAMILIAR WITH THE INSTRUMENT USAGE / HANDLING. LINE R-3.2.7: INADEQUATE USABILITY OF INSTRUMENT DUE TO INADEQUATE DESIGN FOR INTENDED HANDLING PERFORMANCE -> NOT POSSIBLE. A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LINE R-3.2.9: INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE -> NOT POSSIBLE .NOTHING INDICATES AN OFF-LABEL USE OF THE RASP 16/200. HOWEVER, IN ORDER TO REMOVE THE STUCK RASP ABNORMAL PROCEDURES WERE USED, WHICH INTRODUCED ABNORMAL HIGH FORCES ON THE RASP AND THE ADAPTER. IN ADDITION, THE RASP CONNECTOR BUTTON IS DEFORMED, SUGGESTING THAT THE CONNECTION TO THE ADAPTER WAS NOT PROPERLY ALIGNED. CONCLUSION SUMMARY: BASED ON THE RETURNED PRODUCTS AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. THE VISUAL EXAMINATION OF THE RASP 16/200 (REF: 01.00409.623) IN COMBINATION WITH THE GIVEN COMPLAINT REPORT CONFIRMS THAT THE RASP COULD NOT BE REMOVED FROM THE FEMUR USING THE REVITAN ADAPTER AS INTENDED (FENESTRATION OF FEMUR NECESSARY). RASP 16/200 (REF: 01.00409.623) AND ADAPTER (REF: 01.00409.501): THE STUCK RASP 16/200 LED TO ABNORMAL HIGH FORCES APPLIED BY HAMMER BLOWS ON THE REVITAN ADAPTER, WHICH MOST LIKELY CAUSED THE FRACTURE OF ITS STRIKING PLATE. THE DENTS AND SCRATCHES OF THE ADAPTER (HANDLE) WERE CAUSED BY THE ATTEMPT TO REMOVE THE RASP FROM THE FEMUR, USING RASP 14/140 AND RASP 16/140 AS CROSS BAR SUBSTITUTES, AFTER THE ORIGINAL CROSS BAR HAD FALLEN TO THE GROUND. THE DEFORMATION OF THE NOTCH OF THE ADAPTER WAS MOST LIKELY CAUSED BY ANOTHER INSTRUMENT, WHICH WAS PLACED AT THE NOTCH IN ORDER TO KNOCK OUT THE RASP/ADAPTER ASSEMBLY, AFTER THE STRIKING PLATE OF THE ADAPTER HAD BROKEN OFF. DURING REMOVAL THE TEETHS OF THE RASP 16/200 WERE DAMAGED, MOST LIKELY DUE TO COLLISION OF THE RASP WITH THE BLADE OF THE SAW WHEN FENESTRATING OR ANY INSTRUMENT TO REMOVE THE RASP FROM THE FEMUR. IN ADDITION, VISUAL EXAMINATION OF THE DEFORMED RASP 16/200 CONNECTOR BUTTON LED TO THE ASSUMPTION THAT THE COVER OF THE ADAPTER WAS NOT CLOSED AT ALL OR NOT COMPLETELY, LEADING TO AN INPROPER CONNECTION OF THE RASP TO THE REVITAN ADAPTER. RASP 14/140 (REF: 01.00409.612) AND RASP 16/140 (REF: 01.00409.613): AFTER THE CROSS BAR HAD FALLEN TO THE GROUND, TWO ADDITIONAL RASPS (14/140 & 16/140) WERE USED AS CROSS BAR SUBSTITUES. IT APPEARS THE FIRST ATTEMPT USING THE RASP 16/140 FAILED, AS THE DIAMETER OF THE RASP DID NOT FIT THROUGH THE CROSS HOLE FAR ENOUGH. THEN, THE RASP 14/140 WAS USED AS A CROSS BAR SUBSTITUTE, DUE TO ITS SMALLER DIAMETER COMPARED WITH THE RASP 16/140. ALSO THIS ATTEMPT TO REMOVE THE RASP FROM THE FEMUR FAILED. BOTH RASPS (14/140 AND 16/140) SHOW CLEAR SIGNS OF DEFORMATION OF THE TEETHS DUE TO THIS OF OFF-LABEL USE. IMPLANTS REVITAN DISTAL CURVED 16/200 (REF: 01.00406.216) CONNECTED TO REVITAN CYLINDRICAL (REF: 01.00402.095) AND REVITAN DISTAL CURVED 16/260 (REF: 01.00406.316) : BEFORE THE FINAL WEBER STEM WAS IMPLANTED, TWO REVITAN STEMS (16/200 AND 16/260) DID NOT PROPERLY FIT THE PREPARED FEMUR, WHICH CAN BE TRACED BACK TO THE HEAVY FENESTRATION PROCEDURE PREVIOUSLY APPLIED TO REMOVE THE STUCK RASP. THE QUALITY RECORDS OF ALL REPORTED PRODUCTS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE A MANUFACTURING ISSUE SEEMS VERY UNLIKELY. CONCLUDING, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE STUCK RASP 16/200 (REF: 01.00409.623). AS THE RASP WAS STUCK IN THE FEMUR, ABNORMALLY HIGH FORCES WERE APPLIED ON THE HANDLE OF THE ADAPTER, WHICH LED TO ITS FRACTURE AND CONSECUTIVELY TO ALL FURTHER REPORTED DAMAGES AND DIFFICULTIES REPORTED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING MEDWATCH REPORTS ARE CONNECTED TO THIS REPORT: 0009613350-2017-01680, 0009613350-2017-01681, AND 0009613350-2017-01676.

    Additional Manufacturer Narrative · 1

    X-RAYS AND PHOTOGRAPHS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E CLS BREVIUS KINECTIV RASP SZ8) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY ON (B)(4) 2017 THE REVITAN, RASP, DISTAL, CURVED, 16/140 COULD NOT BE REMOVED FROM THE FEMUR AS EXPECTED. WHILE REMOVING THE RASP IT GOT BROKEN. IT WAS ALSO REPORTED THAT THE SURGERY WAS DELAYED FOR 120 MINUTES. NOTES: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848166 REVITAN, RASP, DISTAL, CURVED, 16/140 N/A HTR ZIMMER GMBH N/A 14.095943

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R