BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 PAT PLANER BLDE/CTR DRL MD

    MDR report key: 22114533 · Received May 30, 2025

    Report

    Report Number
    1818910-2025-08751
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 7, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWE
    UDI-DI
    10603295251453
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H3, H6 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE SP2 PAT PLANER BLDE/CTR DRL MD IS REMAIN ATTACHED TO THE SP2 PAT PLANER BODY MED, HOWEVER THE ASSEMBLY AREA OF THE PLANER BODY LOOKS DEFORMED AND WORN. ADDITIONALLY THE LOT NUMBER OF THE BLADE WAS UNABLE TO BE RETRIEVED DUE TO THE JAMMED CONDITION A FUNCTIONAL TEST WAS PERFORMED AND AFTER MULTIPLE ATTEMPTS REVEALED THAT THE BLADE WAS UNABLE TO MOVE DUE TO THE OBSERVED CONDITION ON THE PLANAR BODY, CONFIRMING THE JAMMED AND UNABLE TO DISASSEMBLE ALLEGATIONS. 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 SP2 PAT PLANER BLDE/CTR DRL MD WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. 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. A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS RETRIEVED FOR THIS DEVICE DUE TO THE CONDITION (JAMMED) OF THE RETURNED DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLADE GOT STUCK ON THE MEDIUM PATELLA REAMER AND DID NOT COME OFF. THE RED KNOB ON THE SIDE OF THE ATTUNE FEMORAL INTRODUCER FELL OFF WHEN IMPACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9776 SP2 PAT PLANER BLDE/CTR DRL MD DRILL GUIDES HWE DEPUY ORTHOPAEDICS INC US 10603295251453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female