BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDING/CUTTING PLIERS

    MDR report key: 5578538 · Received April 14, 2016

    Report

    Report Number
    9680938-2016-10045
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Report Date
    March 30, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING DATE: JANUARY 18TH, 2016, LOT # 391.962, LOT T124831. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. ALL PARTS WERE CHECKED 100% FOR FUNCTION AT THE FINAL INSPECTION ON (B)(4) 2016. NO NCRS WERE GENERATED DURING PRODUCTION. 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 SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE 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.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE RETURNED INSTRUMENTS WERE EXAMINED AND, IN EACH INSTANCE, THE COMPLAINT CONDITIONS WERE ABLE TO BE CONFIRMED AS THE BENDING JAW CARBIDE INSERTS WERE FOUND TO BE DAMAGED AND MISSING SEGMENTS: BOTTOM JAW OF LOT T976874 AND BOTH JAWS OF LOT T124831. IN EACH INSTANCE, THE MISSING FRAGMENTS WERE APPROXIMATELY 2.5MM X 2MM X 0.5MM. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER, THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH ROUGH HANDLING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS WITH NO COMPLAINT-RELATED ISSUES IDENTIFIED. THE BENDING/CUTTING PLIERS ARE NOTED IN NINE SYSTEM TECHNIQUE GUIDES INCLUDING: UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE, 1.5MM LCP MODULAR MINI FRAGMENT, AND LOCKING CALCANEAL PLATE. IN EACH SYSTEM, THE INSTRUMENT IS AVAILABLE FOR CUTTING AND CONTOURING OF PLATES TO BETTER FIT PATIENT ANATOMY. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USES OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS WITH NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES IDENTIFIED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER, THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH ROUGH HANDLING. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 TWO (2) BENDING/CUTTING PLIERS WERE DISCOVERED IN STERILE PROCESSING WITH THE TIPS BROKEN OFF. IT IS UNKNOWN ON WHAT DATE THE DEVICES WERE BROKEN. THERE WAS NO REPORTED PATIENT OR SURGICAL INVOLVEMENT OR DELAY. THIS REPORT IS 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233651 BENDING/CUTTING PLIERS PLIERS, SURGICAL HTC SYNTHES TUTTLINGEN T124831

    Patients

    Seq Age Sex Outcome Treatment
    1