BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 12685222 · Received October 22, 2021

    Report

    Report Number
    2939274-2021-06258
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Report Date
    September 27, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982188779
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H10 ADDITIONAL NARRATIVE: PART #: 314.291. SYNTHES LOT #: 07.0434. SUPPLIER LOT #: N/A. RELEASE TO WAREHOUSE DATE: NOT AVAILABLE. MANUFACTURED BY: BÄCHLER FEINTECH AG. VISUAL INSPECTION: THE COMPLAINT DEVICE, SLIDING MECHANISM (PRODUCT CODE: 314.291, LOT NUMBER: 07.0434) WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. UPON VISUAL INSPECTION, THE SYNTHETIC SCREENS WERE FOUND MISSING. THE HANDLE ON THE ITEM WAS CRACKED AND BROKEN. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED ONE OF THE COLLINEAR CLAMP HANDLES WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE SYNTHETIC SCREENS WERE MISSING AND THE HANDLE WAS BROKEN & CRACKED. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE REASON FOR REPAIR IS BROKEN/CRACKED HANDLE. THE ITEM IS BEING SCRAPPED AS IT COULD NOT BE REPAIRED PER THE INSPECTION SHEET AND WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING DATE WAS NOT AVAILABLE, HENCE CURRENT REVISION OF DRAWING WAS REVIEWED. COLLINEAR REDUCTION CLAMP. DIMENSIONAL INSPECTION: THIS WAS NOT PERFORMED AS THE INTERNAL COMPONENTS OF THE DEVICE COULD NOT BE ACCESSED WITHOUT THE DESTRUCTION OF THE HAND PIECE. COMPLAINT CONFIRMED: YES, THE COMPLAINT CAN BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. INVESTIGATION CONCLUSION: THE REDUCTION CLAMP WAS DAMAGED AND MISSING THE SYNTHETIC SCREENS. HENCE, THE COMPLAINT WAS CONFIRMED. THE DEVICE WAS NOT REPAIRED AS IT IS BEING REPLACED UNDER WARRANTY. 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

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 SLIDING MECHANISM WAS BROKEN WHERE THE HANDLE AND THE HEAD OF THE REDUCTION CLAMP MEET. IT WAS STATED THAT IT CAME OUT OF STERILIZATION WITH THE HANDLE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SLIDING MECHANISM. THIS IS REPORT 1 OF 1 FOR (B)(4). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581049 SLIDING MECHANISM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.291 10886982188779

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown