BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH PLATE CUTTERS

    MDR report key: 3911307 · Received July 2, 2014

    Report

    Report Number
    9612488-2014-10260
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE.: UNKNOWN DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. RETURNED TO MANUFACTURER. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 03.211.007, LOT 2651905 WAS RECEIVED IN REASONABLY GOOD CONDITION SAVE FOR THE DISTAL MOST JAW BROKEN OFF AT THE RETAINING PIN AND LOOSE IN THE PACKAGE. THE REMAINING BACKEND OF THE JAW REMAINS WITHIN ITS JAW SLOT. MESH PLATE CUTTERS ARE ROUTINELY RECOMMENDED FOR USE AS PART OF THE SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE FOREFOOT/MIDFOOT SYSTEM IS INDICATED FOR FIXATION OF OSTEOTOMIES, FUSIONS, FRACTURES, NON-UNIONS, MAL-UNIONS AND RE-PLANTATIONS OF SMALL BONES AND SMALL BONE FRAGMENTS IN ADULT AND ADOLESCENT (12¿21 YEARS) PATIENTS, INCLUDING THE FOOT AND ANKLE, AND PARTICULARLY IN OSTEOPENIC BONE. THE CUTTERS ARE INTENDED TO CUT THE MESH PLATE TO FIT PATIENT ANATOMY. THE RECEIVED DEVICE SHOWS EVIDENCE OF SIGNIFICANT WEAR AT THE EDGE OF BOTH CUTTING JAWS. IF THE DEVICE WAS USED IN THIS WORN CONDITION EXCESSIVE FORCE WAS LIKELY APPLIED TO THE JAW EVENTUALLY CAUSING THE BREAKAGE PARTICULARLY IF USED TO CUT MULTIPLE ROWS OF A MESH PLATE. PER THE TECHNIQUE GUIDE, IT IS RECOMMENDED WHEN CUTTING MULTIPLE ROWS TO USE THE LARGE CABLE CUTTER 391.906 (CABLE CUTTER, LARGE). THE CUTTING JAW WEAR INDICATES EXCESSIVE HEAVY CUTTING HAS OCCURRED AND WEAR INSPECTION WAS NOT PERFORMED BETWEEN USES. EXCESS FORCE APPLIED TO THE DULL CUTTING JAWS OF THIS DEVICE HAS RESULTED IN THE JAW BREAKAGE AND LED TO THIS COMPLAINT. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED VINTAGE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. IT IS APPARENT THAT THIS DULL PLATE CUTTER WAS SUBJECTED TO FORCES BEYOND WHAT IT IS DESIGNED FOR AND WAS USED IN A MANNER OTHER THAN THE RECOMMENDED WHICH HAS LED TO THIS CONFIRMED COMPLAINT. THE DEVICE DESIGN IS DETERMINED TO BE SUITABLE FOR ITS INTENDED AND THIS COMPLAINT, NOT THE RESULT OF A DESIGN DEFICIENCY. 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 SEVERAL INSTRUMENTS WERE FOUND DAMAGED DURING CLEANING AND STERILE PROCESSING. THREE STARDRIVE SCREWDRIVERS, HAVE ALL BECOME WORN AND NO LONGER ARE CAPABLE OF PICKING UP SCREWS. ONE MESH PLATE CUTTER IS BROKEN INTO TWO PARTS AT ONE OF THE END PIECES. ONE HEXAGONAL SCREWDRIVER IS BROKEN AND MISSING THE TIP. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385633 MESH PLATE CUTTERS INSTRUMENT,CUTTING,ORTHOPAEDIC HTZ SYNTHES BETTLACH 2651905

    Patients

    Seq Age Sex Outcome Treatment
    1