BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP MBT KEEL PUNCH IMPACT

    MDR report key: 11652932 · Received April 12, 2021

    Report

    Report Number
    1818910-2021-07699
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWA
    UDI-DI
    10603295227441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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 WHILE PUTTING INSTRUMENTS TOGETHER, I FOUND THE SIGMA KEEL PUNCH HANDLE WAS MISSING THE SCREW AND SPRING. IT WAS TOGETHER IN THE SURGERY SO IT PROBABLY FELL APART IN DECON. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550659 HP MBT KEEL PUNCH IMPACT KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET HWA DEPUY ORTHOPAEDICS INC US 9505-02-024 J0709 10603295227441

    Patients

    Seq Age Sex Outcome Treatment
    1