BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER 700 GRAMS

    MDR report key: 6216053 · Received December 30, 2016

    Report

    Report Number
    2520274-2016-15819
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    FZY
    UDI-DI
    10886982202819
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS NOT AVAILABLE AS THE DEVICE IS OLDER THAN 15 YEARS. AT THIS TIME THE MANUFACTURING DOCUMENTS FOR INSTRUMENTS HAD TO BE STORED FOR 10 YEARS. 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

    A PRODUCT DEVELOPMENT INVESTIGATION: THE 399.420 LOT NUMBER 2067120 HAMMER, 399.430 LOT NUMBER 2047 HAMMER AND 398.540 LOT NUMBER 2045 STRAIGHT BALL SPIKE WERE RETURNED AND REPORTED TO HAVE BECOME BROKEN. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER TEN YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE 399.420 AND 399.430 HAMMERS ARE INSTRUMENTS ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM TECHNIQUE GUIDE. THE 398.540 STRAIGHT BALL SPIKE IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM CANNULATED TIBIAL NAILS SYSTEM TECHNIQUE GUIDE. THE DEVICES WERE RETURNED AND REPORTED TO HAVE BECOME BROKEN. THIS CONDITION IS CONFIRMED; BOTH OF THE HAMMERS ARE MISSING PORTIONS OF THE PHENOLIC HANDLE, AND THE VERY DISTAL TIP OF THE BALL SPIKE APPEARS TO HAVE SHEARED OFF. IT IS LIKELY THAT OVER TEN YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE 399.42 HAMMER WAS MANUFACTURED IN 7/2003 AND IS OVER THIRTEEN YEARS OLD. THE BALANCE OF EACH OF THE RETURNED DEVICES IS IN CONDITION CONSISTENT WITH THEIR ADVANCED AGE. DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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. UPON REVIEW OF THE DEVICE HISTORY RECORD, NO NCRS GERMANE TO THE COMPLAINT CONDITION WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAMMER 500 GRAMS, STRAIGHT BALL SPIKE 337MM AND HAMMER 700 GRAMS WERE NOTICED TO BE BROKEN DURING THE DECONTAMINATION PROCESS. THERE WAS NO PATIENT OR CASE INVOLVEMENT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866649 HAMMER 700 GRAMS HAMMER, SURGICAL FZY SYNTHES USA 2047 10886982202819

    Patients

    Seq Age Sex Outcome Treatment
    1