BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    MDR report key: 5807412 · Received July 19, 2016

    Report

    Report Number
    9680938-2016-10100
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 5, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS CONFIRMED. THE RETURNED FORCEPS WERE RECEIVED IN TWO PIECES. THE RIGHT HANDLE/ARM HAS SHEARED OFF JUST PROXIMAL TO THE HINGE. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, 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. PER THE TECHNIQUE GUIDE, THE 398.41 REDUCTION FORCEPS ARE AN INSTRUMENT ROUTINELY USED IN THE 2.4MM LCP DISTAL RADIUS SYSTEM. THE MADE TO DRAWING AND CURRENT DRAWING WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. MOST LIKELY DUE TO APPLICATION OF EXCESSIVE LOAD ON THIS 8 YEAR OLD REUSABLE INSTRUMENT. IT IS NOT LIKELY THAT THE DESIGN CONTRIBUTED TO THIS COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING DATE: 25-NOV-2008, PART# 398.41/ LOT# T930229. NO ISSUES WERE FOUND AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE, MATERIAL, COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS, CERTIFICATION. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CTQ FEATURES AND FOR FUNCTION. 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 DURING AN OLECRANON (LEFT) CASE THE REDUCTION FORCEPS WITH POINTS BROKE WHILE THE SURGEON WAS TRYING TO CLOSE THE CLAMPS. THE STEM OF THE POINTED REDUCTION FORCEP BROKE. THE FRAGMENT STEM WAS RETRIEVED. THE SURGERY WAS NOT DELAYED AND NO HARM WAS REPORTED TO THE PATIENT. ANOTHER POINTED REDUCTION FORCEP WAS AVAILABLE FOR THE SURGEON TO USE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457207 REDUCTION FORCEPS WITH POINTS BROAD-RATCHET FORCEPS HTD SYNTHES TUTTLINGEN T930229

    Patients

    Seq Age Sex Outcome Treatment
    1