BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG HP REV TC3 BOX TRIAL SZ5

    MDR report key: 12666315 · Received October 20, 2021

    Report

    Report Number
    1818910-2021-23063
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    October 8, 2021
    Report Date
    October 8, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295081364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE WAS RECEIVED FOR EXAMINATION; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. 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 : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED. H10 ADDITIONAL NARRATIVE: ADDED: B5 CORRECTED: B3.

    Description of Event or Problem · 0

    A. ACCOUNT NAME: THIS WAS A LOANER TRAY FROM OUR OFFICE. B. PLEASE PROVIDE THE DATE OF EVENT. THIS COMPLAINT WAS RECEIVED ON (B)(6) 2021. I DON¿T KNOW WHEN THE ACTUAL DAMAGE OCCURRED. I ONLY NOTICED IT WHEN I HAD THE INSTRUMENT SENT IN. C. PLEASE PROVIDE THE LOT NUMBER OF THE SIG HP REV TC3 BOX TRIAL SZ5. OUR OFFICE NOW HAS THE INSTRUMENT TO BE SENT BACK SO THEY I CAN¿T GET THE LOT # PERSONALLY ANYMORE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (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 ORANGE PIECE WITHIN SIGMA REV SZ 5 BOX TRIAL WAS FOUND TO BE RIPPED/DAMAGED PRIOR TO THE CASE. THERE WAS BACKUPS, SO THIS DID NOT EFFECT THE PATIENT OR CASE OUTCOME AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565055 SIG HP REV TC3 BOX TRIAL SZ5 KNEE INSTRUMENT : FEMORAL TRIALS HWT DEPUY IRELAND - 9616671 2011-03-015 10603295081364

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown