BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO HANDLE SMALL W SWIVEL

    MDR report key: 11950411 · Received June 7, 2021

    Report

    Report Number
    1526439-2021-01146
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    LXH
    UDI-DI
    10705034532622
    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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR AO HANDLE SMALL W SWIVEL WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM881101 WAS RELEASED IN A SINGLE BATCH. BATCH1: RELEASED ON OCTOBER 15, 2019 WITH NO DISCREPANCIES. BATCH2: RELEASED ON OCTOBER 10, 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. VISUAL INSPECTION: THE AO HANDLE SMALL W SWIVEL 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 SMALL W SWIVEL 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 · 0

    THIS IS REPORT 4 OF 5 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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, THAT THE AO HANDLES FROM THE DEPUY SYNTHES SPINE SYMPHONY SYSTEM, AND BINDING AND HARD TO TAKE APART. THERE ARE SIGN OF RUST ON THE CONNECTION AS WELL. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) AO HANDLE SMALL W SWIVEL. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848242 AO HANDLE SMALL W SWIVEL MISC ORTHO SURGICAL INSTR LXH MEDOS INTERNATIONAL SàRL CH 2020-00-500 KM881101 10705034532622

    Patients

    Seq Age Sex Outcome Treatment
    1 AO HANDLE MEDIUM W RATCHET| AO HANDLE MEDIUM W RATCHET| AO HANDLE SMALL W SWIVEL| AO HANDLE TORQ LIMITING 3.0NM