BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER

    MDR report key: 9695513 · Received February 11, 2020

    Report

    Report Number
    3013730328-2020-00009
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    May 15, 2019
    Report Date
    February 3, 2020
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260397080849
    PMA / PMN Number
    K170503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    NURSE

    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: B5: E1: INITIAL REPORTER'S EMAIL H4: MANUFACTURE DATE UPDATED H3, H6: INVESTIGATION SUMMARY DEVICE HISTORY LOT A REVIEW OF THE RECEIVING INSPECTION (RI) FOR HAMMER WAS CONDUCTED IDENTIFYING THAT THE LOT NUMBER E17DI0395 WAS RELEASED IN A SINGLE BATCH. ¿ BATCH1: LOT QTY OF 15 UNITS WERE RELEASED ON (B)(6) 2017 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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 · 0

    ADDITIONAL EVENT INFORMATION MANUFACTURER DATE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUBMISSION NUMBER K172888. A REVIEW OF THE RECEIVING INSPECTION (RI) FOR HAMMER WAS CONDUCTED IDENTIFYING THAT THE LOT NUMBER E17DI0395 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON OCTOBER 2, 2017 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. VISUAL INSPECTION: THE HAMMER (P/N: PET60250, LOT #: E17DI0395) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE THREADS WERE STRIPPED. THE WELD USED TO HOLD THE SHAFT IN PLACE WAS BROKEN AND THERE WERE SCRATCHES ON THE DEVICE THAT ARE CONSISTENT TO THE DEVICE USE AND HAVE NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED COMPONENTS OF THE DEVICE. FUNCTIONAL TEST: THE FUNCTIONAL TEST WAS PERFORMED ON THE RETURNED DEVICE. THE POLY IMPACTION CAP WAS ABLE TO ASSEMBLE WITH THE HAMMER WITH NO ISSUES FOUND. THE SHAFT WAS ABLE TO ASSEMBLE BUT THE WELD TO HOLD THE DEVICE WAS BROKEN LETTING THE SHAFT TO DISASSEMBLE FROM THE HEAD. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICES? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE HAMMER (P/N: PET60250, LOT #: E17DI0395) AS THE THREADS WERE STRIPPED AND THE WELD WAS BROKEN WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN UNKNOWN PROCEDURE THE HEAD OF THE HAMMER STARTED TO MOVE AND SEPARATE FROM THE NECK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160231 HAMMER MISC ORTHO SURGICAL INSTR MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH PET60250 E17DI0395 04260397080849

    Patients

    Seq Age Sex Outcome Treatment
    1