BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 3.5MM CORTEX SCREWS

    MDR report key: 12821623 · Received November 16, 2021

    Report

    Report Number
    8030965-2021-09549
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    August 28, 2021
    Report Date
    August 28, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    UDI-DI
    07611819796928
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER IS A SYNTHES EMPLOYEE. PART # 319.091, LOT # H762606, MANUFACTURING SITE: (B)(4), SUPPLIER: SYNTHES USA HQ, INC, RELEASE TO WAREHOUSE DATE: MAY 7, 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE COMPLAINT DEVICES DEPTH GAUGE FOR CORTEX SCREWS (PRODUCT CODE: 319.091, LOT NUMBER: H762606) WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. DURING VISUAL INSPECTION, THE DEPTH GAUGE NEEDLE APPEARED BENT AND THE SLIDER HAD SCRATCHES CONSISTENT WITH USAGE. FUNCTIONAL TEST: A FUNCTIONAL TEST OF ASSEMBLING AND DISASSEMBLING THE BODY OF THE DEPTH GAUGE OVER THE SLIDER WAS PERFORMED. DURING THE TEST, IT WAS OBSERVED THAT THE BODY FELT TIGHT AGAINST THE SLIDER WHEN SLIDING UP AND DOWN. THE BODY WAS FOUND SCRATCHING THE SLIDER DURING OPERATION. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? YES, THE COMPLAINT CONDITION CAN BE REPLICATED DURING FUNCTIONAL TEST. DIMENSIONAL INSPECTION: THE INNER DIAMETER OF THE TWO EXTREMITIES OF THE DEPTH GAUGE BODY MEASURED DIMENSION WAS CONFORMING. MEASURING DEVICE USED: CALIPER. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF DRAWING WERE REVIEWED. DEPTH GAUGE FOR 3.5MM PELVIC SCREWS, BODY DEPTH GAUGE, SLIDER ASM, DEPTH GAUGE. COMPLAINT CONFIRMED: YES, THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHYSICAL DEVICE INVESTIGATION. CONCLUSION: THE DEPTH GAUGE BODY AND SLIDER WERE CREATING FRICTION WHEN SLIDING. THE GAUGE NEEDLE ORIENTATION WAS NOT CORRECT AND APPEARED TO BE BENT. THIS COULD HAVE REASON FOR THE COMPLAINT CONDITION. HENCE, THE COMPLAINT WAS CONFIRMED. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE 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 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE CLAMPING SLEEVE DOES NOT TAKE THE SCREW EASILY AND DEPTH GAUGE DOES NOT SLIDE EASILY MAKING MEASUREMENT DIFFICULT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718650 DEPTH GAUGE FOR 3.5MM CORTEX SCREWS GAUGE, DEPTH HTJ SYNTHES GMBH H762606 07611819796928

    Patients

    Seq Age Sex Outcome Treatment
    1 Male HOLD-SL F/314.070 314.550+314.570| UNK - SCREWS: TRAUMA