BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW INSERTER

    MDR report key: 11815503 · Received May 12, 2021

    Report

    Report Number
    8030965-2021-03885
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Report Date
    May 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819642515
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. INVESTIGATION SUMMARY: INVESTIGATION FLOW: DAMAGE / DEVICE INTERACTION / FUNCTIONAL. VISUAL INSPECTION: THE TFNA SCREW INSERTER (PART #: 03.037.025, LOT #: L142174) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO DEFECTS WITH THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. THE COMPLAINT CAN BE REPLICATED WITH THE RETURNED DEVICE(S). FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE WITH THE RETURNED MATING DEVICE CONNECSCR F/TFNA HELIC BLADE+SCR, PART #: 03.037.026, LOT #: L181947. THE DEVICES SHOWED SOME RESISTANCE WHILE ASSEMBLING/ DISASSEMBLING DUE TO THE STRIPPED THREADS OF THE MATING DEVICE (PART #: 03.037.026) AND WERE NOT ASSEMBLE/ DISASSEMBLE AS INTENDED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THERE WAS NO EVIDENCE OF DAMAGE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. THE COMPLAINT WAS CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THERE WERE NO BENT FEATURES OBSERVED WITH THE DEVICE. HOWEVER, THE DAMAGED THREADS OF THE MATING DEVICE CAUSED DEVICE INTERACTION ISSUE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 HISTORY LOT: PART: 03.037.025, LOT: L142174, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: DEC. 07, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE INSTRUMENT WAS FOUND BENT UPON INSPECTION WHILE IS IN SALES CALL. THERE WAS NO SURGERY AND PATIENT INVOLVEMENT ARE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SCREW INSERTER. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708777 SCREW INSERTER ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH L142174 07611819642515

    Patients

    Seq Age Sex Outcome Treatment
    1