BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 6117968 · Received November 21, 2016

    Report

    Report Number
    9612488-2016-10478
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 31, 2016
    Report Date
    October 31, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: AUGUST 19, 2014. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. ONE DRIVING CAP (PART 03.010.523, LOT 8953338) WAS RETURNED FOR INVESTIGATION. THE DRIVING CAP SHOWS REGULAR USE, WITH HAMMER MARKS AND GOUGES ON THE HEAD OF THE DEVICE CONSISTENT WITH HIGH IMPACT FORCE. THE DISTAL THREADED TIP OF THE DRIVING CAP IS BROKEN OFF AND WAS RETURNED STUCK IN THE RETURNED CONCOMITANT DEVICE (PART 03.010.487, LOT 8333956). ALTHOUGH THE EXACT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED, THE DAMAGE APPEARS TO BE THE RESULT OF HAMMERING ON THE DEVICE BEFORE IT WAS FULLY SEATED AGAINST THE INSERTION HANDLE. THE INSTRUMENT(S) ARE USED DURING FEMORAL AND TIBIAL NAIL IMPLANTATIONS AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN SEVERAL TECHNIQUE GUIDES. THE RETURNED DEVICES ARE MULTI USE AND ARE USED FOR IMPLANTED NAILS. THE RELEVANT 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. THE RETURNED CONCOMITANT DEVICE IN THIS COMPLAINT RECORD SHOW NO EVIDENCE OF HAVING CONTRIBUTED TO THE EVENT, AND NO PRODUCT DESIGN OR MANUFACTURING RELATED ISSUE WAS IDENTIFIED WITH THESE CONCOMITANT DEVICES UPON A VISUAL INSPECTION. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. 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 THE THREADS ON THE THREADED DRIVING CAP BROKE INSIDE OF A RADIOLUCENT INSERTION HANDLE DURING AN INTRAMEDULLARY NAIL PROCEDURE OF THE LEFT FEMUR ON (B)(6) 2016. THE DRIVING CAP AND INSERTION HANDLE WERE USED TO SEAT AN 11MM TITANIUM CANNULATED RETRO/ANTEGRADE FEMORAL NAIL-EX/440MM-STERILE INTO THE FEMUR. WHILE HAMMERING THE DRIVING CAP WITH A NON-SYNTHES HAMMER, THE THREADS OF THE DRIVING CAP BROKE INTO TWO PIECES. IT WAS A CLEAN BREAK; NO FRAGMENTS GENERATED. THE THREADS REMAIN IN THE INSERTION HANDLE. THE SURGEON PROCEEDED WITH SURGERY USING THE SAME DRIVING CAP AND INSERTION HANDLE. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: NAIL (PART 04.013.568S, LOT UNKNOWN, QUANTITY 1); INSERTION HANDLE (PART 03.010.487, LOT 8333956, QUANTITY 1); NON-SYNTHES HAMMER (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769447 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 8953338

    Patients

    Seq Age Sex Outcome Treatment
    1 1 PART 03.010.487, LOT 8333956, INSERTION HANDLE| 1 PART 04.013.568S, LOT UNKNOWN, NAIL| 1 UNKNOWN NON-SYNTHES HAMMER