BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

    MDR report key: 6291098 · Received January 31, 2017

    Report

    Report Number
    9680938-2017-10014
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Report Date
    January 10, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    UDI-DI
    10886982202253
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL NARRATIVE:. A PRODUCT INVESTIGATION WAS PERFORMED. PART # 399.051, LOT NUMBER # T100628 (REDUCTION FORCEPS) WAS RETURNED AND REPORTED TO HAVE BEEN FOUND BROKEN DURING STERILE PROCESSING. THIS CONDITION IS CONFIRMED; THE THREADED SPEED LOCK SHAFT HAS BROKEN OFF APPROXIMATELY SIXTEEN MILLIMETERS FROM THE BASE OF THE SHAFT. IT IS LIKELY THAT OVER TWO YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION, HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE DEVICE WAS MANUFACTURED IN 4/2014 AND IS OVER TWO YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE FAIR CONDITION WITH SOME MARKINGS, DISCOLORATION, AND OTHER SIGNS OF WEAR. A 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. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. UPON REVIEW OF THE DEVICE HISTORY RECORD, NO NCRS GERMANE TO THE COMPLAINT CONDITION WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. ALL MEASUREMENTS HAVE BEEN PERFORMED BY CALIPERS (B)(4). 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 PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 399.051, LOT# T100628. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: APR 29, 2014. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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 APR 29, 2014. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 A BROKEN REDUCTION FORCEPS WITH SERRATED JAW WAS REPORTED BY STERILE PROCESSING. THE DEVICE WAS BROKEN INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH SERRATED JAW 240MM ¿SPEED LOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71830 REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK FORCEPS HTD SYNTHES TUTTLINGEN T100628 10886982202253

    Patients

    Seq Age Sex Outcome Treatment
    1