BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG HP REV TORQ LMT SCRWDRVR

    MDR report key: 11691362 · Received April 19, 2021

    Report

    Report Number
    1818910-2021-08270
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 1, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HXX
    UDI-DI
    10603295436379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    DURING THE OPERATING THE DOCTOR FOUND THE FOLLOWING DEFECTS: ON SLEEVE BROACH 37 THE CARD STEMS CANNOT BE PUT ON IT. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. PART NUMBER 860284 NEEDS TO BE REPLACED IT NO LONGER TORQUED. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. ARTICLE NUMBER 201103080 IS DEFECTIVE. THE PLASTIC IS TORN ON THE INSIDE. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581835 SIG HP REV TORQ LMT SCRWDRVR KNEE INSTRUMENT : TORQUE DEVICES HXX DEPUY IRELAND - 9616671 2011-03-080 BV698145 10603295436379

    Patients

    Seq Age Sex Outcome Treatment
    1