BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON HARD BONE DRILL

    MDR report key: 8965806 · Received September 5, 2019

    Report

    Report Number
    1221934-2019-58202
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 7, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWE
    UDI-DI
    10886705025527
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6: THE COMPLAINT DEVICE WAS NOT RETURNED AFTER MULTIPLE ATTEMPTS FOR DEVICE RETURN, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. SHOULD THE DEVICE EVER BE RECEIVED BACK IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (1707001), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT A MANUFACTURER RECORD EVALUATION WAS PERFORMED AND RESULTS WERE OBTAINED AS FOLLOWS: PRODUCT : 211601 LOT NUMBER : 1707001 ANOMALIES OR DISCREPANCIES (NON-CONFORMANCE) : NONE 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

    (B)(4). 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

    IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2019 THE ANCHOR FRACTURED SLIGHTLY DURING INSERTION AND GRYPHON HARD BONE DRILL WAS FOUND TO BE BLUNT. SURGEON WAS ABLE TO REMOVE ALL FRAGMENTS OF THE ANCHOR WITH NO ISSUE. THERE WAS INCREASED SURGICAL TIME OF 30 SECONDS. THERE WAS NO ADVERSE CONSEQUENCE TO PATIENT. IT WAS LATER REPORTED THAT THE CASE WAS COMPLETED WITH ANOTHER DRILL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759589 GRYPHON HARD BONE DRILL CANNULATED SURGICAL DRILL HWE DEPUY MITEK LLC US 1707001 10886705025527

    Patients

    Seq Age Sex Outcome Treatment
    1