BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 11272659 · Received February 3, 2021

    Report

    Report Number
    2939274-2021-00647
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Report Date
    January 15, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWN
    UDI-DI
    10886982076267
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: VISUAL INSPECTION: THE COMPRESSION FORCEPS (PART #: 03.211.400, LOT #: T961260) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE SMALL LEAF SPRING (PART # SE_091689) WAS BROKEN INTO TWO DISTINCT PIECES. THE BRAKEAGE OCCURRED AT THE JUNCTION WHERE THE M2.5X6 SCREW (PART # 008.167) IS SCREWED INTO THE SMALL LEAF SPRING TO HOLD IT IN PLACE. DISCOLORATION WAS ALSO NOTICED AT SOME AREAS OF THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO REQUIRING DESTRUCTION OF THE DEVICE, AND DEVICE ASSEMBLY AND GEOMETRY LIMITS ABILITY TO ACCURATELY DIMENSIONALLY INSPECT. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE SMALL LEAF SPRING (PART # SE_091689) WAS BROKEN INTO TWO DISTINCT PIECES ON THE RETURNED COMPLAINT DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION BUT IT IS LIKELY THE DEVICE EXPERIENCED EXCESSIVE LOAD THAT WAS GREATER THAT WHAT THE DEVICE WAS VALIDATED TO WITHHOLD. 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 HISTORY LOT: PART NUMBER: 03.211.400, LOT NUMBER: T961260, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: JUNE 14, 2011. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. 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. CORRECTED DATA: H3, H6.

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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 AN UNKNOWN DATE, IN THE STERILE PROCESSING DEPARTMENT THE FORCEPS WERE FOUND WITH A BROKEN SPRING. THE TRAY WAS TAGGED AS BROKEN. THIS REPORT INVOLVES 1 COMPRESSION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170390 COMPRESSION FORCEPS INSTRUMENT, COMPRESSION HWN WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.211.400 T961260 10886982076267

    Patients

    Seq Age Sex Outcome Treatment
    1