BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 6412017 · Received March 16, 2017

    Report

    Report Number
    9680938-2017-10045
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Report Date
    February 22, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: NO PATIENT INVOLVEMENT REPORTED. EVENT DATE: UNKNOWN. 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. (B)(6). A SERVICE HISTORY REVIEW HAS BEEN REQUESTED. 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

    NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 399.99 WITH LOT NUMBER(S) T924810/5834610 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 8-JUL-2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART# 399.99 LOT# T924810: MANUFACTURING DATE: 15-JUL-2008. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES 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 COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR IMPORTANT FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 14-JUL-2008. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. A PRODUCT INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICE. TWO (2) 399.99 REDUCTION FORCEPS WITH LOT NUMBERS T957301 AND T924810 WERE RETURNED AND REPORTED TO NO LONGER RATCHET. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER SIX YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, DEVICE HISTORY REVIEW (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. THE 399.99 REDUCTION FORCEPS ARE INSTRUMENTS ROUTINELY USED IN THE SMALL FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM PER RELEVANT TECHNIQUE GUIDE. THE DEVICE WAS RETURNED AND REPORTED TO NO LONGER RATCHET. THIS CONDITION IS CONFIRMED; THE DEVICE DOES RATCHET TO A LIMITED EXTENT BUT THE MECHANISM IS LOOSE AND NOT CONSISTENT ON EITHER DEVICE. IT IS LIKELY THAT OVER SIX YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. LOT T957301 WAS MANUFACTURED IN 1/2011 AND IS OVER SIX YEARS OLD. LOT T924810 WAS MANUFACTURED IN 7/2008 AND IS OVER EIGHT YEARS OLD. THE BALANCE OF THE RETURNED DEVICES IS IN OTHERWISE FAIRLY GOOD CONDITION WITH ONLY SOME SUPERFICIAL WEAR. RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED 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

    (B)(6) REPORTED THAT UPON INSPECTION IT WAS NOTICED THAT THE REDUCTION FORCEPS WITH SERRATED JAW WAS NOT RATCHETING. THERE ARE 2 DEVICES IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193613 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD SYNTHES TUTTLINGEN T924810

    Patients

    Seq Age Sex Outcome Treatment
    1