BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 10624009 · Received October 2, 2020

    Report

    Report Number
    1818910-2020-21557
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 21, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HXC
    UDI-DI
    10603295239789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE HEX CONNECTION FEATURE IS STRIPPED. THE INVESTIGATION FINDINGS DID NOT INDICATE THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT THE PRODUCT D961673 IS WORN AND NEEDS TO BE REPLACED, THE BLACK END THAT GOES OVER THE IMPLANT TO TIGHTEN WAS SLIPPING WHEN THE SURGEON WAS PUTTING IMPLANTS TOGETHER. PRODUCT D217863109 AND D217863111 ARE NOT HOLDING STEM TRIALS WELL DUE TO THE WEAR AT THE CONNECTION SITE. NEEDS TO BE REPLACED. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087400 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT : TORQUE DEVICES HXC DEPUY ORTHOPAEDICS INC US 96-1673 SO2012913 10603295239789

    Patients

    Seq Age Sex Outcome Treatment
    1