BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM DRILL BIT/QC/165MM

    MDR report key: 8773764 · Received July 9, 2019

    Report

    Report Number
    8030965-2019-66112
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 12, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819245891
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 310.284, LOT: L930010, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 12.JUNE 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INVESTIGATION: THE RECEIVED DEVICE IS IN A USED CONDITION. THE CUTTING LIPS ARE SLIGHTLY WORN. OTHERWISE THE DRILL BIT IS IN PERFECT CONDITION. INVESTIGATION CONCLUSION: AFTER A VISUAL INSPECTION, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS APPROPRIATE. 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 RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A CLAVICLE DIAPHYSEAL FRACTURE, THREE (3) DRILL BITS WERE NOTED TO BE DULL AND THE DRILLING TOOK TIME. THUS, THE SURGEON USED AN UNKNOWN K-WIRE INSTEAD AND PENETRATED THE CONTRALATERAL BONE BEFORE DRILLING AGAIN. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. THE PATIENT WAS STABLE AFTER THE OPERATION. ANOTHER SURGEON COMMENTED THAT HE WANTED THE DRILL BIT TO BE IMPROVED OR CHANGED TO A DISPOSABLE DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565917 2.8MM DRILL BIT/QC/165MM BIT DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH L930010 07611819245891

    Patients

    Seq Age Sex Outcome Treatment
    1