BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER FOR REAMING GUIDES

    MDR report key: 13601039 · Received February 25, 2022

    Report

    Report Number
    1818910-2022-03587
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 25, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295116127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS RETURNED FOR EXAMINATION. THE VISUAL EXAMINATION OF THE DEVICE FOUND THE INSIDE THREAD WAS STRIPPED. THE DEVICE WAS TESTED WITH A ROD FOR REAMING GUIDE HOLDER LOT#5082900 AND IT WAS HARD TO FULLY INSERT THE DEVICE, CONFIRMING THE REPORTED ALLEGATION. 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). A MANUFACTURING RECORDS EVALUATION MRE WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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 BEREVIEWED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS INSERTING THE PROXIMAL REAMING STEM WHICH WAS LOADED ON THE PROXIMAL REAMING GUIDE HANDLE. HE MALLETED THE PROXIMAL REAMER GUIDE AND GOT HUNG UP. HE RETIRED AND MALLETED A LITTLE MORE. THE PROXIMAL REAMING GUIDE HOLDER IM ROD ON THE SCREW IN SIDE BROKE RIGHT OFF. THE IM ROD WAS STUCK INSIDE THE HANDLE. WE COULDN¿T GET THE IM ROD TO DISENGAGE. SURGICAL DELAY OF 10 MINUTES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359001 HOLDER FOR REAMING GUIDES EXTREMITY INSTRUMENTS : HANDLES LXH DEPUY ORTHOPAEDICS INC US 2307-74-001 2397062 10603295116127

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female