BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR LOCKING SCREWSTO 100MM FOR IM NAILS

    MDR report key: 5694900 · Received June 2, 2016

    Report

    Report Number
    1719045-2016-10450
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Report Date
    May 17, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (DEPTH GAUGE FOR LOCKING SCREWSTO 100MM FOR IM NAILS, PART NUMBER 03.010.072, LOT NUMBER 9253411). THE SUBJECT DEVICE WAS RECEIVED WITH THE COMPLAINT REPORTING THAT THE INSTRUMENT WAS NOT MEASURING CORRECTLY. THE SHAFT OF THE SUBJECT DEVICE WAS RECEIVED WITH A BENT SHAFT. THE COMPLAINT CONDITION WAS CONFIRMED. THE COMPLAINT CONDITION WAS DUE TO THE BENT TIP AND THIS WAS MOST LIKELY WAS CAUSED BY ROUGH HANDLING IN STERILE PROCESSING AND WEAR/TEAR OVER THE LIFE OF THE INSTRUMENT, RATHER THAN THE DESIGN OF THE INSTRUMENT. WHILE THIS IS THE LIKELY CAUSE, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED DEPTH GAUGE IS AN ADDITIONAL INSTRUMENT USED DURING FEMORAL, TIBIAL, AND HUMERAL NAIL IMPLANTATIONS FOR DETERMINING THE LENGTH OF LOCKING SCREW, ITS PROPER USE AND MAINTENANCE ARE ADDRESSED IN THE ASSOCIATED TECHNIQUE GUIDES. THE DRAWING FOR THE DEVICE WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. SUBSEQUENT REVISIONS OF THE DRAWING DO NOT IMPACT THE COMPLAINT CONDITION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. PART: 03.010.072, LOT: 9253411, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28.NOV.2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    CLARIFICATION: ONLY THE THREE REPORTED DEPTH GAUGES WERE DETERMINED TO HAVE REPORTABLE MALFUNCTIONS AND WERE REPORTED UNDER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CLEANING UP WITHIN THE STERILE PROCESSING DEPARTMENT FIVE DEVICES WERE FOUND BROKEN. THE FIRST REPORTED DEVICE - STARDRIVE SCREWDRIVER T8 ¿ HAS A PIECE ON THE BACK OF THE HANDLE THAT FALLS OFF OF THE DEVICE. THE SECOND REPORTED DEVICE ¿ HANDLE WITH QUICK COUPLING, SMALL ¿ HAS A PIECE ON THE END OF THE HANDLE THAT WILL NOT TWIST. THE THREE OTHER REPORTED DEVICES ¿ DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS ¿ ARE ALL MEASURING WRONG. THE ISSUES WITH THESE DEVICES WERE NOT DISCOVERED WITHIN A SURGICAL FIELD. NO OTHER INFORMATION COULD BE PROVIDED. THIS COMPLAINT INVOLVES THREE DEVICES. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349136 DEPTH GAUGE FOR LOCKING SCREWSTO 100MM FOR IM NAILS GAUGE, DEPTH HTJ SYNTHES MONUMENT 9253411

    Patients

    Seq Age Sex Outcome Treatment
    1