BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT 1.5 W/HOLD-SLEEVE L66

    MDR report key: 3286467 · Received August 14, 2013

    Report

    Report Number
    1719045-2013-01882
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN SINCE THE EVALUATION OF THIS DEVICE IS ONGOING. THE MANUFACTURING RECORDS WERE REQUESTED SINCE THE LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT SYNTHES MONUMENT ASSEMBLED THE STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM, PART NUMBER 03.114.009, LOT NUMBER 7054679. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 25 PARTS WERE RELEASED TO THE WAREHOUSE ON OCTOBER 09, 2012.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SHOWED THAT THE TIP IS BROKEN OFF. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT IS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. BASED ON THE FINDINGS WE HAVE TO ASSUME THAT HIGH APPLIED MECHANICAL FORCE DURING SCREW TIGHTENING CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, WHILE INSERTING A LOCKING SCREW (LCP COHA SET) THE TIP OF SCREWDRIVER BROKE. PART 03.114.009 CONCERNS AN ASSEMBLY GROUP, BUT ONLY SCREWDRIVER (PART 03.114.010, LOT 7010083) WAS SENT FOR INVESTIGATION, THE HOLDING SLEEVE WAS NOT AVAILABLE. THIS IS 1 OF 1 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390141 SCRDRIVER SHAFT 1.5 W/HOLD-SLEEVE L66 HXX SYNTHES MONUMENT 7054679

    Patients

    Seq Age Sex Outcome Treatment
    1