BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE188MM

    MDR report key: 5242939 · Received November 23, 2015

    Report

    Report Number
    3003875359-2015-10497
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    November 7, 2015
    Report Date
    November 7, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FSM
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW ¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 16.MAY.2006. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE FOLLOWING DEVICE(S) WAS RECEIVED: PERCUTANEOUS INSERTION HANDLE (PART # 03.010.046 / LOT # 1828305); AIMING ARM FOR ANTEGRADE STANDARD LOCKING (PART # 03.010.049 / LOT # 1801722); CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSERTION HANDLE (03.010.146 / LOT #U156819); 12.0MM/8.0MM PROTECTION SLEEVE (PART # 03.010.063 / LOT # 1482819); 8.0MM/4.2MM DRILL SLEEVE (PART # 03.010.065 / LOT # 1438693) THE RETURNED DEVICES WERE EXAMINED AND FOUND TO BE IN GOOD CONDITION WITH MINIMAL COSMETIC DAMAGE. NO FUNCTIONAL DAMAGE WAS FOUND ON THE RETURNED DEVICES. THE INSTRUMENTS WERE ABLE TO BE ASSEMBLED AND WERE FOUND TO FUNCTION AS INTENDED. DUE TO THE TIGHT TOLERANCES AND DESIGN, THE CONSTRUCT IS SUSCEPTIBLE TO LATERAL FORCES DURING THE SURGERY THAT ARE UNABLE TO BE REPLICATED. IT IS LIKELY THAT SOFT TISSUE DISTRACTION FORCES ARE THE CAUSE OF THIS COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS AND IN EACH INSTANCE NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOTS NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT DURING PROXIMAL LOCKING OF A RETROGRADE/ANTEGRADE FEMORAL NAIL, MULTIPLE ATTEMPTS TO PASS THE LONG 4.2MM CALIBRATED DRILL BIT THROUGH THE GUIDED AIMING ARM FAILED. RADIOGRAPHIC IMAGES CONFIRMED THE GUIDE/INSERTION HANDLE WAS MISDIRECTING THE DRILL BIT POSTERIORLY IN RELATION TO THE HOLE IN THE NAIL. STEPS WERE TAKEN TO FREEHAND THE DRILL BIT FOR BOTH PROXIMAL LOCKING SCREWS. THE PATIENT WAS NOT AFFECTED AND A DESIRABLE OUTCOME WAS REACHED WITH GOOD RESULTS. THERE WAS A TEN MINUTE DELAY. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774917 12.0MM/8.0MM PROTECTION SLEEVE188MM TRAY, SURGICAL, INSTRUMENT FSM SYNTHES HAGENDORF 1482819

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR