BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

    MDR report key: 6508344 · Received April 20, 2017

    Report

    Report Number
    3009417901-2017-10012
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 20, 2017
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HTD
    UDI-DI
    10886982202314
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 5000673. MANUFACTURING LOCATION: (B)(6). DATE OF MANUFACTURE: MARCH 24, 2003. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE, PART NUMBER 399.091, LOT NUMBER 5000673). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: THIS COMPLAINT IS CONFIRMED. THE RETURNED DEVICE WAS RECEIVED IN 2 PIECES AT CQ. ONE OF THE ARMS HAS SHEARED IN HALF JUST PROXIMAL TO THE DEVICE'S HINGE. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY BROKEN. IT IS DETERMINED THAT THE DEVICE BROKE INTRAOPERATIVELY (ARM SHEARED IN HALF) AND DEVICE WAS BARELY HELD TOGETHER BY THE CENTRAL RATCHET MECHANISM UNTIL STERILE PROCESSING WHERE IT SEPARATED INTO 2 PIECES. THEREFORE, BROKE INTRAOPERATIVELY SELECTED FOR THIS INVESTIGATION SUMMARY. NO FRAGMENTS APPEAR TO HAVE BEEN GENERATED AS THE TWO SHEAR SURFACES MATE TOGETHER WITH NO VOIDS. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED DEVICE WAS RECEIVED IN 2 PIECES AT CQ. ONE OF THE ARMS HAS SHEARED IN HALF JUST PROXIMAL TO THE DEVICE'S HINGE. DRAWING WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. MOST LIKELY DUE TO APPLICATION OF EXCESSIVE FORCE ON THIS (B)(4) YEAR OLD REUSABLE INSTRUMENT. 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 THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA SHAFT TO TREAT A FRACTURE. WHILE THE SURGEON WAS USING THE REDUCTION FORCEPS ONE OF THE HANDLES SNAPPED AND WAS PARTIALLY DETACHED. THAT INSTRUMENT WAS SET ASIDE AND AN ALTERNATE WAS AVAILABLE FOR THE SURGEON TO USE AND SUCCESSFULLY COMPLETE THE PROCEDURE. AFTER THE INSTRUMENT WENT THROUGH STERILIZATION PROCESS IT BROKE INTO (2) SEPARATE PIECES. THERE WAS NO SURGICAL DELAY TO THE PROCEDURE. NO HARM WAS REPORTED TO THE PATIENT. THE PATIENT OUTCOME WAS STABLE. REPORTEDLY, THE INSTRUMENT HAD BEEN IN USE A LONG TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291501 BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE FORCEPS HTD SYNTHES SALZBURG 5000673 10886982202314

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR