BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 90MM STERILE

    MDR report key: 5729309 · Received June 16, 2016

    Report

    Report Number
    3003506883-2016-10099
    Event Type
    Injury
    Date Received
    June 16, 2016
    Report Date
    May 31, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: UPDATED INFORMATION. DATE RETURNED TO MANUFACTURER. UPDATED INFORMATION, CONCOMITANT PART ADDED. SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE RETURNED IMPLANT IS PART OF THE DEPUY SYNTHES TFNA ADVANCED (TFNA) PROXIMAL FEMORAL NAILING SYSTEM. THE HELICAL BLADE IS USED TO PREVENT THE NAIL FROM ROTATING ONCE FINAL POSITION AND LOCKING HAS TAKEN PLACE. BASED ON THE X-RAYS PROVIDED ABOVE (X-RAYS_POST-OPERATIVELY.PDF) THE BLADE IS SEEN PROTRUDING TOWARDS THE FEMORAL HEAD. VISUAL INSPECTION OF THE IMPLANT SHOWED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT AS BLADE IS IN FAIR CONDITION WITH WEAR CONSISTED WITH BEING IMPLANTED/EXPLANTED. THE IMPLANT WAS TESTED WITH THE CONCOMITANT DEVICE (11MM/130 DEG TI CANN TFNA 170MM ¿ STERILE; PART NUMBER: 04.037.142S LOT NUMBER 9960203) AND SHOWED NO ISSUES. THE FOLLOWING COMPLAINT DEVICE WAS RECEIVED BY CUSTOMER QUALITY (CQ): ONE TFNA HELICAL BLADE 90MM STERILE (PART NUMBER: 04.038.290S, LOT NUMBER: 9806819, MFG. DATE: 29JUN2015) THE DEVICE WAS RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿SURGICAL REVISION TOOK PLACE ON (B)(6) 2016 TO REPLACE WITH ARTIFICIAL FEMORAL HEAD DUE TO PROTRUDING THE REPORTED BLADE (OF TFNA) FROM THE HEAD OF THE FEMUR¿. THE COMPLAINT CONDITION IS CONFIRMED. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT, WHERE APPLICABLE, WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. PLEASE NOTE 04.037.142S LOT NUMBER 9960203 WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. (B)(4). (B)(6). THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA 90MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. HOWEVER THERE WAS 1 PART SCRAPPED AT THE SHOT PEEN OPERATION FOR A SURFACE FINISH ISSUE. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    UPDATE: CONCOMITANT PART: 1X 04.005.522 / 9637938 (LOCKSCR Ø5 L32 F/NAILS TAN LIGHT GREEN). THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO REPLACE A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) BLADE WHICH WAS PROTRUDING FROM THE PATIENT'S FEMORAL HEAD. THE PATIENT WAS REVISED WITH A PROSTHETIC FEMORAL HEAD. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016. THE FOLLOWING COMMENTS WERE FURTHER REPORTED: "THE SURGEON REDUCED THE REPORTED BLADE EXTRAMEDULLARY DURING THE SURGERY; THE REPORTED BLADE GRADUALLY MIGRATED INTRAMEDULLARY 1 TO 2 WEEKS AFTER THE SURGERY; THE MIGRATION MIGHT OCCUR DUE TO THE NAIL BEING PLACED POSTERIORLY A LITTLE BIT DURING THE SURGERY; ALTHOUGH THE PATIENT FELL FROM BED [ON AN UNKNOWN DATE] IN (B)(6) 2016 ONCE, IT MIGHT NOT BE THE EXACT CAUSE OF THIS TROUBLE ITSELF." NO SURGICAL DELAY WAS REPORTED DURING THE REVISION SURGERY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385335 TFNA HELICAL BLADE 90MM STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 9806819

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention