BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 4212614 · Received October 30, 2014

    Report

    Report Number
    2520274-2014-14409
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART RETURNED FOR INSPECTION. DURING EVALUATION THE REPAIR TECHNICIAN REPORTED THE RATCHET WAS NOT LOCKING AND THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. 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 DEVELOPMENT EVALUATION WAS COMPLETED: THE PART WAS RETURNED WITH THE HANDLES SLIGHTLY LOOSE CAUSING THE RATCHETING MECHANISM TO NOT WORK PROPERLY. THE INSTRUMENT SHOWS SIGNS OF WEAR WITH A DEEP SCRATCH AT THE TIP AND SPOT OF DISCOLORATION ON THE HANDLE. FIVE REDUCTION FORCEPS WITH SERRATED JAW, RATCHET, (PART 399.99, LOTS 4791274/A7NA22, 5119852/A7OA38, A7AA006, 5451418/A7QA05, 4114272/A7JA18) WERE RETURNED FOR THE RATCHET LOCKING MECHANISM REPORTEDLY NOT WORKING. PER THE TECHNIQUE GUIDE, THE FORCEPS ARE USED TO REDUCE AND SECURE AXIAL ALIGNMENT OF FRAGMENTS PRIOR TO FIXATION FOR THE 2.7 AND 3.5MM PLATING SYSTEMS. SETS TYPICALLY INCLUDE OTHER RATCHETING REDUCTION FORCEPS SUCH AS 398.41 OR 398.40. THREE OF THE FIVE RETURNED FORCEPS WERE FOUND TO BE RATCHETING AND LOCKING WELL. THE FORCEPS WITH LOT 4114272 (MANUFACTURING DATE MAY 2000) AND A7AA006 (MANUFACTURING DATE UNKNOWN) WERE FOUND TO HAVE THE RING HANDLES SLIGHTLY LOOSE CAUSING THE RATCHET TO NOT LOCK WHEN NOT MANUALLY ALIGNED. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION AND FOUND TO BE ADEQUATE FOR THE DEVICES INTENDED USE. THE DIMENSIONS AND TOLERANCES OF THE COMPONENTS ALLOW FOR THE RATCHETING MECHANISM TO LOCK AS INTENDED. IT IS UNLIKELY THE DESIGN CONTRIBUTED TO THIS COMPLAINT CONDITION. THERE ARE NO FUNCTIONAL DESIGN REQUIREMENTS FOR DURABILITY/USE LIFE AND PARTS SHOULD BE INSPECTED BEFORE USE. THEREFORE, THE DESIGN IS ADEQUATE FOR THE INSTRUMENT¿S INTENDED USE. (B)(4). 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

    A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED.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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A REVIEW OF THE SERVICE HISTORY HAS BEEN REQUESTED. 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 BY THE SERVICE AND REPAIR DEPARTMENT FROM THE SALES CONSULTANT ON THE FOLLOWING ISSUES WITH FIELD EQUIPMENT: ONE DEPTH GAUGE HAS A NEEDLE THAT IS BENT AND OUT OF ALIGNMENT. THERE ARE FIVE REDUCTION FORCEPS THAT NEED TO BE TIGHTENED SO THAT RATCHET LOCKING MECHANISM WORKS. ALSO; THERE ARE TWO REDUCTION FORCEPS WITH POINTS BROAD-RATCHET THAT ALSO NEED TO BE TIGHTENED SO RATCHET LOCKING MECHANISM WORKS. THE SALES CONSULTANT CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND THAT THE ISSUE WAS FOUND OUTSIDE OF THE OPERATING ROOM. THIS REPORT IS 3 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696567 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD SYNTHES USA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1