BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    MDR report key: 6768437 · Received August 4, 2017

    Report

    Report Number
    1719045-2017-10738
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Report Date
    July 26, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWA
    UDI-DI
    10886982193292
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THIS COMPLAINT IS DUPLICATE AS THIS EVENT WAS CAPTURED IN (B)(4). 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. S&R SERVICE HISTORY REVIEW FOR PART 338.26. LOT 4152302 HAS BEEN REQUESTED. THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A CRUCIFORM SCREWDRIVER SHAFT IS BENT, THE WIRE OF A DEPTH GAUGE IS BENT AND AN IMPACTOR HEAD ON A DHS SET IS BROKEN (ONE PIECE IS CHIPPED OFF AND IS MISSING). THESE WERE DISCOVERED UPON ROUTINE INSPECTION AT A METRO OFFICE. NO KNOWN PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549414 TIP FOR DHS®/DCS® IMPACTOR (338.28) IMPACTOR HWA SYNTHES MONUMENT 4152302 10886982193292

    Patients

    Seq Age Sex Outcome Treatment
    1