BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SPREADER 7MM BEAK WIDTH

    MDR report key: 13018477 · Received December 16, 2021

    Report

    Report Number
    2939274-2021-07114
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 18, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982201980
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE COMPLAINT DEVICE, BONE SPREADER 7MM BEAK WIDTH (PRODUCT CODE: 398.93, LOT NUMBER: T190585) WAS RETURNED TO CQ WEST CHESTER FOR INVESTIGATION. UPON VISUAL INSPECTION, THE THREADED SHAFT AND SPRING LEAF WERE FOUND BROKEN. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE "SPRING" THAT APPLIES TENSION OF THE BONE SPREADER 7MM BEAK WIDTH WAS BROKEN. THE THREADED SHAFT AND SPRING LEAF WAS REPORTED BROKEN BY THE REPAIR TECHNICIAN. THE CAUSE OF THE ISSUE AND THE REASON FOR REPAIR WERE DAMAGED COMPONENT. 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: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF DRAWINGS WERE REVIEWED. DIMENSIONAL INSPECTION: THIS IS IDENTIFIED TO BE A POST MANUFACTURING DAMAGE, HENCE A DIMENSIONAL INSPECTION WAS NOT PERFORMED. INVESTIGATION CONCLUSION: THE COMPONENTS OF THE BONE SPREADER WAS FOUND BROKEN. 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. H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 398.93; LOT # T190585; MANUFACTURING SITE: TUTTLINGEN; RELEASE TO WAREHOUSE DATE: 20 JAN 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, THE "SPRING" THAT APPLIES TENSION OF THE BONE SPREADER 7MM BEAK WIDTH WAS BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR (1) BONE SPREADER 7MM BEAK WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919661 BONE SPREADER 7MM BEAK WIDTH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 398.93 T190585 10886982201980

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown