BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT

    MDR report key: 3983365 · Received August 6, 2014

    Report

    Report Number
    3003875359-2014-10231
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 MANUFACTURING EVALUATION WAS COMPLETED: WE FOUND THAT THE TOP PART OF THE CLAMP SHAFT IS BROKEN OFF. THE FRAGMENT WAS NOT SENT BACK FOR EVALUATION. THEREFORE NOT ALL RELEVANT DIMENSIONS CAN BE VERIFIED AND THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH (B)(4) THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION OF 47 +5/0 HRC BACK THEN. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. ALSO THERE ARE MARKS OF HAMMER BLOWS VISIBLE AT THE FRACTURE FACE, WHICH WERE APPARENTLY CAUSED AFTER THE TOP PART BROKE OFF. NEXT TO THAT THERE ARE CLEAR WEAR MARKS AND DEFORMATIONS AT THE TRAIL IMPLANT ITSELF, WHICH INDICATES THAT THIS WAS AN OFTEN AND INTENSE USED DEVICE BEFORE IS BROKE. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6). IT WAS REPORTED THAT THE TRIAL SPACER WAS DAMAGED. IT IS UNKNOWN WHEN THIS EVENT OCCURRED OR IF A PATIENT WAS INVOLVED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459956 T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT TEMPLATE HWT SYNTHES HAGENDORF 7542766

    Patients

    Seq Age Sex Outcome Treatment
    1