BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN STRAIGHT CUP IMPACTOR

    MDR report key: 11777092 · Received May 5, 2021

    Report

    Report Number
    1818910-2021-09550
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWA
    UDI-DI
    10603295098980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED, BUT A PHOTO WAS PROVIDED CONFIRMING THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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). 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

    WHILE IMPACTING A PINNACLE SECTOR 2 SZ 56 SHELL INTO THE PATIENT¿S ACETABULUM THE BACK PART OF THE PINNACLE CUP INSERTER HANDLE BROKE INTO TWO PIECES. NO FRAGMENTS WERE GENERATED OTHER THAN THE TWO PIECES THAT WERE RECOVERED AND THERE WAS NO ADVERSE EFFECT ON PATIENT. THERE WAS A TIME DELAY OF 1 MINUTE AS THE REPS WENT FOR A SECOND IMPACTOR. DR. L IS VERY FRUSTRATED AND DISAPPOINTED IN THE QUALITY OF THIS INSTRUMENT AS HE HAS HAD MANY OF THESE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673119 PINN STRAIGHT CUP IMPACTOR HIP INSTRUMENTS : IMPACTORS HWA DEPUY ORTHOPAEDICS INC US 2217-50-041 NB122501 10603295098980

    Patients

    Seq Age Sex Outcome Treatment
    1