BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 6064565 · Received October 28, 2016

    Report

    Report Number
    9612488-2016-10435
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ONE DRIVING CAP (PART # 03.010.523, LOT # 8953345) 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 NOT RETURNED STUCK IN THE RETURNED CONCOMITANT DEVICE. 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. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT CONDITION IS CONFIRMED. THE INSTRUMENT(S) ARE USED DURING FEMORAL AND TIBIAL NAIL IMPLANTATIONS AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN THE 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. 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. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. CALIPERS WERE USED FOR ALL DIMENSIONAL INSPECTIONS/MEASUREMENTS. 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. THEREFORE, REVIEW TO THE SPECIFIC DESIGN IS NOT APPLICABLE. 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. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS INVESTIGATION. 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. 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 AGE AND WEIGHT WERE NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE RESULTS ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER, 8953345. MANUFACTURER: (B)(4). DATE OF MANUFACTURE: AUG 18, 2014. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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, WHILE INSERTING A NAIL DURING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE, THE DRIVING CAP BROKE OFF IN THE INSERTION HANDLE. FRAGMENTS WERE GENERATED, BUT WERE RETRIEVED EASILY WITHOUT ADDITIONAL MEDICAL INTERVENTION. THERE WAS ANOTHER DRIVING CAP AND INSERTION HANDLE READILY AVAILABLE FOR USE. A SURGICAL DELAY OF LESS THAN FIVE (5) MINUTES WAS REPORTED; THE SURGICAL DELAY WAS DUE TO OPENING A SECOND SET TO REPLACE INSTRUMENTS. THERE WAS NO PATIENT HARM REPORTED; PATIENT OUTCOME REPORTED AS "SUCCESSFUL." THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: HYBRID INSERTION HANDLE (PART # 03.037.011, LOT # 9561887, QUANTITY 1), TROCHANTERIC FIXATION NAIL ADVANCED (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716078 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BETTLACH 8953345

    Patients

    Seq Age Sex Outcome Treatment
    1 03.037.011, HYBRID INSERTION HANDLE| ONE, UNKNOWN TROCHANTERIC FIXATION NAIL ADVANCED