BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC

    MDR report key: 6442714 · Received March 29, 2017

    Report

    Report Number
    1719045-2017-10271
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    February 27, 2017
    Report Date
    March 6, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    UDI-DI
    07611819307711
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.228, LOT# 6032305. MANUFACTURED BY: (B)(4), RELEASE TO WAREHOUSE DATE: OCT 10, 2008. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017, THE DRILL BIT BROKE. NO DELAY IN SURGERY WAS REPORTED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227162 DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC BIT, DRILL HTW SYNTHES MONUMENT 6032305 07611819307711

    Patients

    Seq Age Sex Outcome Treatment
    1