BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 TIBIAL RADEL IMPACTOR

    MDR report key: 7564922 · Received June 4, 2018

    Report

    Report Number
    1818910-2018-61211
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 8, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    HWA
    UDI-DI
    10603295147916
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED DAMAGE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 STATED THAT UPON USING THE TIBIAL IMPACTOR D2581-11-000 TO IMPLANT THE TIBIA, THE POLY PORTION OF THE DEVICE CRACKED DURING USE . PART NUMBER 2307-87-005 THE METAGLENE HANDLE IS WORN OUT, NOT HOLDING THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS STATED THAT UPON USING THE TIBIAL IMPACTOR D2581-11-000 TO IMPLANT THE TIBIA THE INSTRUMENT BROKE. PART NUMBER 2307-87-005 WORN OUT, NOT HOLDING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407753 SP2 TIBIAL RADEL IMPACTOR KNEE INSTRUMENT : IMPACTORS HWA DEPUY ORTHOPAEDICS INC 1818910 SY1213 10603295147916

    Patients

    Seq Age Sex Outcome Treatment
    1