BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    MDR report key: 6447318 · Received March 30, 2017

    Report

    Report Number
    3003875359-2017-10154
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    March 11, 2017
    Report Date
    March 11, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    UDI-DI
    10886982190604
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: PART # 323.034, LOT # 9093905; MANUFACTURING SITE: (B)(4); MANUFACTURING DATE: 12 AUG. 2014. NO NCRS 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. 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 DEVELOPMENT INVESTIGATION WAS COMPLETED. A VISUAL INSPECTION, DRAWING REVIEW AND DHR REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE RETURNED DRILL GUIDE WAS FOUND TO HAVE SOME RUST AROUND THE ETCHING. NO SUBSTANTIAL WEAR WAS OBSERVED TO THE THREADS OF THE DEVICE. THE LCP PLATE WAS NOT RETURNED THEREFORE REPLICATION OF THE COMPLAINT WAS UNABLE TO BE TESTED. RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT 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

    ADDITIONAL NARRATIVE: 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 THE DURING A FOOT FUSION ON (B)(6) 2017, THE THREADED DRILL GUIDE WOULD NOT THREAD INTO THE MINI FRAGMENT 2.0MM LCP PLATE. WHEN THE DRILL GUIDE WAS SCREWED INTO THE PLATE, THE THREADS OF THE DRILL GUIDE WOULD NOT ENGAGE THE PLATE AND WOULD NOT THREAD IN. THE THREADS APPEARED TO BE WORN. THERE WAS ANOTHER DRILL GUIDE IN THE SET READILY AVAILABLE TO CONTINUE THE PROCEDURE WITHOUT DELAY. THE SURGEON WAS ABLE TO USE THE SAME PLATE. ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED. X-RAYS WERE NOT TAKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT MEDICAL PRODUCTS: 2.0MM LCP PLATE (PART # UNKNOWN, LOT # UNKNOWN, QTY OF 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227823 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE GUIDE FZX SYNTHES HAGENDORF 9093905 10886982190604

    Patients

    Seq Age Sex Outcome Treatment
    1