BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLAP HAMMER WITH QUICK RELEASE

    MDR report key: 3021538 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10410
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    April 23, 2012
    Report Date
    April 23, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SLAP HAMMER WAS RECEIVED FRACTURED AT THE ADAPTOR END. THERE WERE SOME MINOR SCRATCHES ON THE SURFACE AND NICKS ON THE OUTER SLEEVE OF THE QUICK CONNECT. MANUFACTURING INVESTIGATION DETERMINED THAT THE COMPLAINT CONDITION WAS DUE TO AN UNKNOWN CAUSE. THE COMPLAINT WAS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. A PRODUCT DEVELOPMENT EVALUATION WAS ALSO PERFORMED. DESIGN EVALUATION DETERMINED THAT THE SLAP HAMMER BROKE AT THE THREADED CONNECTION DIRECTLY BELOW THE PIN. THIS PIN WEAKENS THE THREADED SHAFT BY REMOVING MATERIAL FROM THE THREADED INTERFACE. IN ADDITION, THE MATERIAL IS NOT OPTIMAL FOR IMPACT RESISTANCE. DUE TO THE RESULT EVALUATIONS, THE COMPLAINT WAS DEEMED VALID FROM A DESIGN PERSPECTIVE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CADAVER LAB, THE SLAP HAMMER BROKE AT THE PIN CONNECTION WHEN THE SURGEON TRIED REMOVING A TRIAL. THE BROKEN FRAGMENT WAS RETRIEVED AND THE PROCEDURE COMPLETED WITH NO FURTHER PROBLEMS.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124724 SLAP HAMMER WITH QUICK RELEASE FZY SYNTHES MONUMENT 6723847

    Patients

    Seq Age Sex Outcome Treatment
    1