BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM

    MDR report key: 7401714 · Received April 5, 2018

    Report

    Report Number
    8030965-2018-52810
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 9, 2018
    Report Date
    March 13, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07612334091369
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: H3, H4, H6: PART 03.130.202S, LOT L641068: MANUFACTURING SITE: SELZACH. SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG. RELEASE TO WAREHOUSE DATE: NOVEMBER 03, 2017. EXPIRY DATE: OCTOBER 01, 2027. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT F-23020 AT THE SUPPLIER SPHINX WERKZEUGE AG AND STERILIZED AFTERWARDS. 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. H10 CORRECTED DATA: D10: DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER. H3, H6: 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 USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART WAS RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS REQUESTED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, ON (B)(6) 2018, SURGERY FOR METACARPAL BONE FRACTURE WAS PERFORMED USING THE VA LOCKING HAND SYSTEM. DURING THE SURGERY, THE DRILL BIT BROKE. WHEN ANOTHER PACKAGE OF DRILL BIT WAS OPENED, IT HAD ALREADY BEEN DEFORMED. THE SURGERY WAS SUCCESSFULLY COMPLETED AND, THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL. THIS COMPLAINT INVOLVES 1 PART. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243746 1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM BIT,DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH L641068 07612334091369

    Patients

    Seq Age Sex Outcome Treatment
    1