BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 6090402 · Received November 9, 2016

    Report

    Report Number
    9612488-2016-10452
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PART #03.010.475, LOT # 7719678. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEBRUARY 20, 2012. 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. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE DRIVING CAP (PART NUMBER 03.010.475, LOT NUMBER 7719678). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE DRIVING CAP IS WELL USED WITH NUMEROUS GOUGES AND MARKS CONSISTENT WITH HAMMERING. THE DISTAL THREADED TIP OF THE DRIVING CAP IS BROKEN OFF AND WAS RETURNED (THE TIP IS APPROXIMATELY 25MM IN LENGTH). THE COMPLAINT IS CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS DEVICE IS ROUTINELY USED TO INSERT THE TROCHANTERIC FIXATION NAIL AS WELL AS TO INSERT THE TI CANNULATED TIBIAL NAIL SUPRAPATELLAR PER TECHNIQUE GUIDES. DRAWINGS FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A 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. A REVIEW OF RISK ASSESSMENT FOUND THE RISK SPECIFIC TO THE COMPLAINT CONDITION ADEQUATELY ADDRESSED. THE EXACT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED, BUT IT WAS LIKELY A COMBINATION OF WEAR COUPLED WITH EXCESSIVE/OFF ANGLE HAMMER BLOWS DURING USE. 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 ON (B)(6) 2016, PATIENT UNDERWENT A TIBIA NAIL INSERTION PROCEDURE. WHILE THE SURGEON WAS HAMMERING INTO THE NAIL, THE DRIVING CAP INSTRUMENT TIP BROKE OFF IN THE INSERTION HANDLE HALF WAY THRU THE NAIL INSERTION. SURGEON COLLECTED THE BROKEN TIP FROM THE PATIENT'S STERILE DRESSING. ANOTHER DRIVING CAP WAS AVAILABLE IN THE OPERATING ROOM AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. DUE TO THIS EVENT AN ADDITIONAL 10 MINUTES WAS ADDED TO OPERATING ROOM TIME. PATIENT WAS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE /TROCHANTERIC FIXATION NAILS (PART #03.010.405, LOT # UNKNOWN., QUANTITY 1). THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741434 DRIVING CAP MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 7719678

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR PART #03.010.405, LOT # UNKNOWN. QUANTITY 1