BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 6633081 · Received June 12, 2017

    Report

    Report Number
    1719045-2017-10566
    Event Type
    Injury
    Date Received
    June 12, 2017
    Report Date
    May 16, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. (B)(4). REPORTER CONTACT NUMBER WAS NOT PROVIDED FOR REPORTING. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.037.012S, LOT# 9938399. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: NOV 25, 2015, EXPIRY DATE: NOV 30, 2025. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. COMPONENT PARTS REVIEWED: PART 04.037.912.2 - LOCK PRONG, 125NDEGREE, TFNA. BP-55 LOT - 9621608. PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT - 7921039. PART 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT - 9910492. PART 21127 - RAW MATERIAL LOT BP-80 LOT - 7957780. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF ANALYSIS AND RAW MATERIAL RECEIVING/ PUT-AWAY CHECKLIST RECEIVED FROM (B)(4). MEET SPECIFICATION. (B)(4). THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT DURING THE REMOVAL OPERATION, A BROKEN PIECE (SAME COLOR LIKE THE NAIL) WAS FOUND IN THE PATIENT¿S BODY AFTER THE IMPLANTS WERE REMOVED. THE REPORTED ISSUE IS CONFIRMED, AS IT IS CLEARLY VISIBLE THAT THE BROKEN PIECE IS FROM THE LOCKING PRONG INSIDE OF THE NAIL. THE NAIL ITSELF HAS NO SIGNS OF DAMAGE BESIDES THE SLIGHT SCRATCHES. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. THE USED MATERIAL WAS TITANIUM AS REQUIRED. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT 9938399 WAS MANUFACTURED IN NOVEMBER 2015 AND ALL PARTS WERE ACCORDING TO SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. HOWEVER, THE BREAKAGE INDICATES THAT THE LOCKING PRONG WAS NOT FULLY DISENGAGED PRIOR TO THE EXTRACTION OF HELICAL BLADE. CONSEQUENTLY MECHANICAL FORCE DURING EXTRACTION, POSSIBLY WITH THE SLIDE HAMMER, MAY HAVE CAUSED THE COMPLAINED ISSUE. IN THIS RELATION, TO PREVENT SUCH SITUATIONS AND FOR MORE DETAILS REGARDING ¿DISENGAGE LOCKING MECHANISM AND REMOVE HELICAL BLADE OR SCREW¿ IS PROVIDED IN THE TECHNIQUE GUIDE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT INITIAL IMPLANT PROCEDURE. ON (B)(6) 2017, PATIENT UNDERWENT REMOVAL PROCEDURE DUE TO CUT-OUT OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL. DURING THE REMOVAL PROCEDURE, BROKEN IMPLANT PIECES WERE FOUND IN THE PATIENT¿S BODY AFTER THE IMPLANTS WERE REMOVED. REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. PATIENT STATUS WAS REPORTED AS GOOD. REPORTED CONCOMITANT DEVICES: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN (PART# 04.005.524, LOT# 9289463, QUANTITY 1). TFNA END CAP EXTENS. 0 TAN (PART# 04.038.000S, LOT# 9301841, QUANTITY 1). TFNA HELICAL BLADE L80 TAN (PART# 04.038.280S, LOT# 9865100, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10 MM/125 DEG TI CANN TFNA 170 MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415831 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9938399

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART# 04.005.524, LOT# 9289463, QUANTITY 1| PART# 04.038.000S, LOT# 9301841, QUANTITY 1| PART# 04.038.280S, LOT# 9865100, QUANTITY 1