BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM ASSEM UPPER PULL ROD

    MDR report key: 22072199 · Received May 22, 2025

    Report

    Report Number
    1818910-2025-08382
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 22, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWB
    UDI-DI
    10603295156017
    PMA / PMN Number
    EXEMPT
    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 IT WAS REPORTED THAT THE ASSEMBLY PULL ROD WAS BENT, THREADED CAP JAMMED IN THE TOP POSITION. IT DID NOT HAPPEN IN SURGERY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE THREADED ROD WAS DEFORMED. ADDITIONALLY, THE THREADED CAP WAS SEIZED IN AN OFF-AXIS POSITION. A FUNCTIONAL TEST WAS PERFORMED MANUALLY AND WAS ABLE TO REPLICATE THE REPORTED JAMMED CONDITION DUE TO THE SUBCOMPONENTS WERE UNABLE TO DISENGAGE AFTER MULTIPLE ATTEMPTS WITH EXCESSIVE FORCES APPLIED. THE OBSERVED CONDITIONS OF THE DEVICE WERE CONSISTENT WITH OFF-AXIS ASSEMBLY, IMPROPER ALIGNMENT AND CARE WHEN ASSEMBLING MATING DEVICE, A COMBINATION OF HEAVY USE AND PRYING MOTION. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE RECLAIM ASSEM UPPER PULL ROD WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USE ERROR AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. H11 ADDITIONAL NARRATIVE: ADDED: D9 CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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. 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 · 0

    IT WAS REPORTED THAT THE ASSEMBLY PULL ROD WAS BENT, THREADED CAP JAMMED IN THE TOP POSITION. IT DID NOT HAPPEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261565 RECLAIM ASSEM UPPER PULL ROD HIP INSTRUMENTS: EXTRACTOR HWB DEPUY IRELAND - 9616671 SO2030571 10603295156017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown