BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET

    MDR report key: 5520382 · Received March 23, 2016

    Report

    Report Number
    3009417901-2016-10011
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Report Date
    March 9, 2016
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A SERVICE HISTORY RECORD REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE BUT COULD NOT BE COMPLETED BECAUSE THE ITEM LOT-CONTROLLED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT (MANUFACTURER LOT/SERIAL NUMBER (B)(4)). THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: ONE REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET (PART 399.092 LOT 5800991) WAS RECEIVED. THIS COMPLAINT IS CONFIRMED, AS THE RETURNED DEVICE DOES NOT FUNCTION AS INTENDED. THE COMPLAINT CONDITION OF WILL NOT CLOSE AND WILL NOT HOLD IN CLOSED POSITION WERE ABLE TO BE REPLICATED. IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY WEAR OVER THE LIFETIME OF THIS 7+ YEAR OLD DEVICE. THE RATCHET MECHANISM APPEARS WORN AND NO LONGER HOLDS AS INTENDED. IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RELEVANT DRAWINGS WERE REVIEWED DURING THIS EVALUATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE 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 REDUCTION FORCEPS HAD TWO ISSUES WHICH WERE DISCOVERED DURING ROUTINE INSTRUMENT INSPECTION. THE POINTS OF THE INSTRUMENT DO NOT COME CLOSE TO TOUCHING AND THE SOFT RATCHET DOES NOT HOLD IN A CLOSED POSITION. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175849 REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET FORCEPS HTD SYNTHES SALZBURG 5870274

    Patients

    Seq Age Sex Outcome Treatment
    1