BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO HANDLE TORQUE LIMITING3.0NM

    MDR report key: 12144781 · Received July 9, 2021

    Report

    Report Number
    1526439-2021-01401
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    LXH
    UDI-DI
    10705034532813
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR PRODUCT DESCRIPTION WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM881262 WAS RELEASED IN FOURTEEN BATCHES. BATCH1: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH2: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH3: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH4: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH5: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH6: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH7: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH8: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH9: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH10: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH11: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH12: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH13: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. BATCH14: RELEASED ON (B)(6) 2019, WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. VISUAL INSPECTION: THE AO HANDLE TORQ LIMITING 3.0NM WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS NOTICED THAT THERE WAS RUST ON THE DEVICE NEAR PULL-RELEASE COUPLING. ALL THREE COMPONENTS WERE ASSEMBLED TOGETHER. FUNCTIONAL TEST: WHEN PULLING ON THE PULL RELEASE AO COUPLING COMPONENT, THE INSIDE SPRING WAS NOT CONTRACTING AND RETRACTING CORRECTLY AS INTENDED. IT LOOKS LIKE THE RUST CONDITION AFFECTED THE SPRING OF THE COMPONENT. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THERE WAS NO DAMAGE THAT WARRANTED A DIMENSIONAL INSPECTION. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RETURNED AO HANDLE TORQUE LIMITING 3NM AS THERE WERE RUST OBSERVED ON THE DEVICE. ALSO, THE FUNCTIONAL ASSESSMENT FAILED AS THE COMPONENTS JAMMED DURING FUNCTIONAL ASSESSMENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REPORTED THAT ON (B)(6) 2021, AO HANDLES FROM THE SYMPHONY SYSTEM WERE BINDING AND HARD TO TAKE APART. THERE ARE SIGNS OF RUST ON THE CONNECTION AS WELL. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR AN AO HANDLE TORQUE LIMITING 3.0NM. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042515 AO HANDLE TORQUE LIMITING3.0NM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDOS INTERNATIONAL SàRL CH 2020-00-504 KM881262 10705034532813

    Patients

    Seq Age Sex Outcome Treatment
    1