BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    MDR report key: 5763314 · Received June 30, 2016

    Report

    Report Number
    9680938-2016-10094
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 15, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING DATE: 19-SEP-2013 398.41/T994366, REVIEW OF THE DEVICE HISTORY RECORD 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, 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 AT THE FINAL INSPECTION ON 17-SEP-2013. NO NCRS WERE GENERATED DURING PRODUCTION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE COMPLAINT DEVICE (REDUCTION FORCEPS WITH POINTS BROAD-RATCHET, PART NUMBER 398.41, LOT NUMBER T994366). THE DEVICE WAS RECEIVED WITH THE COMPLAINT THAT THE DEVICE WAS FOUND TO NOT FUNCTION/WILL NOT HOLD. THE 398.41 REDUCTION FORCEPS ARE AN INSTRUMENT ROUTINELY USED IN THE 2.4MM LCP DISTAL RADIUS SYSTEM PER THE TECHNIQUE GUIDE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. AS PREVIOUSLY REPORTED, THE DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THIS COMPLAINT CONDITION IS CONFIRMED; THE DEVICE NO LONGER HOLDS TENSION/POSITION UNDER FORCES WHEN THE RATCHET MECHANISM IS ENGAGED. THE RIGHT ARM AND LEFT ARM APPEAR SLIGHTLY BENT OUTWARD WHICH WOULD CONTRIBUTE TO A LESS THAN DESIRABLE FUNCTIONING UNDER APPLICATION OF FORCE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT THE INSTRUMENT WAS NOT PROPERLY MAINTAINED AS RECOMMENDED AND EXPERIENCED EXCESSIVE LOAD DAMAGE DURING USE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    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 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 A SURGEON WAS PERFORMING AN ANKLE FRACTURE REPAIR USING A BONE CLAMP AND WHILE HOLDING THE BONE FRAGMENTS TOGETHER, THE REDUCTION FORCEPS KEPT POPPING OPEN. BACK-UP REDUCTION FORCEPS WERE USED AND THE SAME ISSUE OCCURRED. REDUCTION FORCEPS FROM ANOTHER SET WERE BROUGHT IN AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A DELAY OF A FEW MINUTES WAS REPORTED. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417535 REDUCTION FORCEPS WITH POINTS BROAD-RATCHET FORCEPS HTD SYNTHES TUTTLINGEN T994366

    Patients

    Seq Age Sex Outcome Treatment
    1