BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE

    MDR report key: 6710035 · Received July 13, 2017

    Report

    Report Number
    3003875359-2017-10337
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    July 10, 2017
    Report Date
    July 10, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    UDI-DI
    10886982190604
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 323.034, LOT #L211199: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 01.DEC.2016: NO NON CONFORMANCE REPORTS (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. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THAT THE SURGEON WAS NOT ABLE TO THREAD TWO DRILL GUIDES INTO THE LOCKING HOLE OF THE PLATE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FOOT ON (B)(6) 2017. THE GUIDES WERE THEN TRIED IN OTHER PLATES FROM THE SAME MODULE AND THE SAME PROBLEM OCCURRED. IT WAS NOTED THE ISSUES OCCURRED BEFORE USE ON THE PATIENT. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH A SIMILAR DEVICE. CONCOMITANT DEVICES REPORTED: PLATES (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491059 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE GUIDE FZX SYNTHES HAGENDORF L211199 10886982190604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN QUANTITY OF UNKNOWN PLATES