BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 5008212 · Received August 17, 2015

    Report

    Report Number
    9612488-2015-10419
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Report Date
    July 31, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    THERE WAS NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 28 JULY 2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. 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

    ADDITIONAL NARRATIVE: THE FOLLOWING DEVICE WAS RECEIVED: DRIVING CAP (PART # 03.010.523 / LOT # 8953336 / MFG. DATE: 07/2014). A PRODUCT INVESTIGATION WAS PERFORMED: THE RETURNED DEVICE SHOWS LIMITED USE DURING ITS LIFESPAN. THE DISTAL THREADED PORTION OF THE DRIVING CAP HAS SHEARED OFF, AND THE TIP WAS RETURNED. THE DAMAGE TO THE DRIVING CAPS IS MOST LIKELY THE RESULT OF OFF-AXIS HAMMERING ON THE DEVICE BEFORE FULLY SEATING THE DRIVING CAP ON THE AIMING ARM OR FROM CROSS THREADING THE DEVICE. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGNS ARE ADEQUATE FOR THEIR INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INSTRUMENT(S) ARE USED DURING FEMORAL AND ADOLESCENT TIBIAL NAIL IMPLANTATIONS AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN TECHNIQUE GUIDES. THE RETURNED DEVICE IS MULTI USE AND IS USED FOR IMPLANTED NAILS. THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY THE METHOD OF USE RATHER THAN THE DESIGN OF THE INSTRUMENT. 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 TIP OF A DRIVING CAP WAS FOUND TO HAVE BROKEN OFF INTO AN INSERTION HANDLE. THE TIP WAS ABLE TO BE REMOVED FROM THE INSERTION HANDLE. THIS WAS NOTICED OUTSIDE OF ANY PROCEDURE. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542725 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 8953336

    Patients

    Seq Age Sex Outcome Treatment
    1