BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ARM

    MDR report key: 9166931 · Received October 8, 2019

    Report

    Report Number
    2939274-2019-61287
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Report Date
    September 19, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034714486
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. H3, H4, H6: PART#: 03.612.010, SYNTHES LOT#: P160243, SUPPLIER LOT#: NA, RELEASE TO WAREHOUSE DATE: 08 SEP 2009, MANUFACTURED BY SYNTHES MONUMENT, NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE FLEX ARM (PART#: 03.612.010, LOT#: P160243) WAS RETURNED AND RECEIVED AT US CQ. THERE ARE LIGHT SURFACE SCRATCHES ALONG THE HANDLE AND THE ARM OF THE DEVICE AS WELL AS LIGHT DISCOLORATION ON THE DISTAL COUPLING OF THE ARM THAT ARE CONSISTENT WITH NORMAL WEAR. INSPECTING THE INDIVIDUAL ARM SEGMENTS OF THE DEVICE, THERE APPEARS TO BE NO VISIBLE DAMAGE ON THE ARM OR THE CHORD THAT CONNECTS THE DEVICE OTHER THAN ETCH ON THE DEVICE STARTING TO FADE. THE LOW FRICTION WASHERS ON THE TIGHTENING HANDLE APPEAR TO BE WORN AS THEY HAVE CLEAR CIRCULAR WEAR MARKS FROM THE THRUST BEARINGS. FUNCTIONAL TEST: THE KNOB ON THE DEVICE IS EASILY TIGHTENED AND LOOSENED. WHEN FULLY ENGAGED, THE ARM DOES STIFFEN HOWEVER ITS SHAPE CAN STILL EASILY BE ALTERED WITH A LIGHT APPLICATION OF FORCE. FUNCTIONAL TESTING CONFIRMED THE COMPLAINT CONDITION OF THE DEVICE BEING LOOSE. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? YES; FUNCTIONAL TESTING SHOWED THE DEVICE REMAINED LOOSE WHEN THE KNOB IS ENGAGED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE THE RELEVANT DRAWING BEING SOURCE CONTROLLED BY THE SUPPLIER. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. FLEX ARM ASSEMBLY. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED IS LOOSE. HENCE CONFIRMING THE ALLEGATION. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE FLEX ARM (PART#: 03.612.010, LOT#: P160243) AS THE DEVICE DOES NOT COMPLETELY STIFFEN WHEN ENGAGED. WHEN THE KNOB IS ENGAGED TO ITS FURTHEST POINT, THE FLEX ARM CAN STILL BE MANIPULATED THROUGH LIGHT APPLICATIONS OF FORCE. ALTHOUGH NO DEFINITIVE ROOT-CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE EXPERIENCED UNINTENDED FORCES LEADING TO INTERNAL MECHANICAL FAILURES. 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 PREVENTATIVE 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. 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 AN UNKNOWN DATE, THE FLEX ARM FROM THE MIS SUPPORT SYSTEM WILL NOT TIGHTEN DOWN TO THE BED. TWO OF THE ARMS ARE DEFECTIVE. ACTION TAKEN WAS TO OPEN ANOTHER SET. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) FLEX ARM. THIS IS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962123 FLEX ARM MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.612.010 P160243 10705034714486

    Patients

    Seq Age Sex Outcome Treatment
    1