BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING PLIERS 180MM

    MDR report key: 6452488 · Received April 2, 2017

    Report

    Report Number
    9680938-2017-10062
    Event Type
    Malfunction
    Date Received
    April 2, 2017
    Report Date
    March 13, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTC
    UDI-DI
    10886982198334
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE HISTORY REVIEW WAS ATTEMPTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 391.88 WITH LOT NUMBER(S) T924964/6007300 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 16-OCT-2008. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 391.88, LOT# T924964. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 11, 2008. 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 09-SEP-2008. SERVICE AND REPAIR EVALUATION WAS COMPLETED. THE CUSTOMER REPORTED THE LOCKING PLIERS HAD A BROKEN SUPPORT. THE REPAIR TECHNICIAN REPORTED THE TEETH ON THE JAW WERE WORN. WORN OUT PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE DEVICE WAS RETURNED AND REPORTED TO HAVE A BROKEN SUPPORT BY THE CUSTOMER AND HAVE WORN OUT TEETH BY SERVICE AND REPAIR. THE DEVICE IS NOT BROKEN AND NO FRACTURE SURFACES ARE VISIBLE; THIS CONDITION IS UNCONFIRMED. ASSEMBLY AND DISASSEMBLY INSTRUCTIONS CAN BE FOUND IN THE EPOCA REVISION INSTRUMENT SET TECHNIQUE GUIDE. THE TEETH ALONG THE JAWS OF THE DEVICE ARE SOMEWHAT WORN CONSISTENT WITH EIGHT YEARS OF USE. THIS CONDITION IS CONFIRMED. IT IS LIKELY THAT OVER EIGHT YEARS OF CONSISTENT USE HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN 9/2008 AND IS OVER EIGHT YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE FAIRLY WORN CONDITION WITH MARKINGS AND SOME AREAS OF DISCOLORATION ACROSS ITS SURFACE. RELEVANT 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. 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. THERE WAS NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A SERVICE AND REPAIR HISTORY RECORD REVIEW 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

    DEVICE REPORT FROM (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE 180 MM LOCKING PLIERS HAVE A BROKEN SUPPORT. IT IS UNKNOWN WHEN THE INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OR PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234181 LOCKING PLIERS 180MM PLIERS, SURGICAL HTC SYNTHES TUTTLINGEN T924964 10886982198334

    Patients

    Seq Age Sex Outcome Treatment
    1