BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

    MDR report key: 6744446 · Received July 26, 2017

    Report

    Report Number
    9680938-2017-10124
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Report Date
    July 3, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    UDI-DI
    10886982202253
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. IMPLANT AND EXPLANT DATES: 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: PART # 399.051 / LOT # T940008 MANUFACTURING DATE: 22-OCT-2009. 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 32 PARTS OF THE LOT WERE CHECKED 100% FOR IMPORTANT FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 21-OCT-2009. ALL WERE FOUND TO BE CONFORMING. NO NCRS WERE GENERATED DURING PRODUCTION. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE 399.051, LOT NUMBER T940008, REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK WAS RETURNED AND IT WAS REPORTED THAT "THE FORCEPS FOR BROKEN SCREW REMOVAL WILL NOT HOLD AND ARE NOT RATCHETING" THIS COMPLAINT IS CONFIRMED. THE DEVICE WAS RETURNED WITH THE TIP OF ONE OF THE JAWS BROKEN OFF. THE LOCATION OF THE BROKEN TIP FRAGMENT IS UNKNOWN. APPROXIMATELY 9.18 MM (LENGTH) OF THE JAW IS MISSING. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY BROKEN. THE 399.051 REDUCTION FORCEPS ARE AN INSTRUMENT ROUTINELY USED WITH THE 105.90 BONE FORCEPS SET. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, OPPOSITE LOADING/FORCE IS APPLIED TO THE JAWS DURING BONE REDUCTION. THIS COMPLAINT CONDITION IS LIKELY DUE TO EXCESSIVE/CONSISTENT FORCE APPLIED TO THE JAWS OVER THE PART'S LIFETIME (7+ YEARS), CAUSING MATERIAL FATIGUE AND BREAKAGE. 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

    IT WAS REPORTED THAT ON (B)(6) 2017 THAT THE REDUCTION FORCEPS WITH SERRATED JAW ARE BROKEN INTO TWO PIECES, THE FORCEPS FOR BROKEN SCREW REMOVAL WILL NOT HOLD AND ARE NOT RATCHETING AND THE REDUCTION FORCEPS WITH SERRATED JAW WILL NOT HOLD AND ARE LOOSE. ALL THREE DEVICES WERE FOUND IN A BIN IN THE STERILE PROCESSING. THERE IS NO PATIENT 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
    525295 REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK FORCEPS HTD SYNTHES TUTTLINGEN T940008 10886982202253

    Patients

    Seq Age Sex Outcome Treatment
    1