BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS RATCHET 174MM

    MDR report key: 10905299 · Received November 25, 2020

    Report

    Report Number
    2939274-2020-05316
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    October 30, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982203137
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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, H6: PART NUMBER: 399.94; LOT NUMBER: T160066; MANUFACTURING SITE: TUTTLINGEN; RELEASE TO WAREHOUSE DATE: DECEMBER 12, 2017. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND A NC WAS INITIATED DUE TO LASER ETCHING NOT ACCORDING TO THE SPECIFICATIONS. THE NECESSARY ACTIONS TO ENSURE THE FINAL PRODUCT QUALITY HAVE BEEN TAKEN AND DOCUMENTED IN THE APPROPRIATE QUALITY SYSTEM. THE NC HAVE NO IMPACT TO THE COMPLAINT CONDITION. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. VISUAL INSPECTION: THE REDUCTION FORCEPS WITH POINTS RATCHET 174 MM (P/N: 399.94, LOT #: T16066) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL TIP WAS BENT AND DEFORMED. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. THERE WERE NO SIGNS OF BROKEN OBSERVED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED: REDUCTION FORCEPS WITH POINTS RATCHET. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE REDUCTION FORCEPS WITH POINTS RATCHET 174 MM (P/N: 399.94, LOT #: T16066). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. THE POTENTIAL CAUSE FOR THE DEFORMED DISTAL TIP COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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. REPORTER IS A SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REDUCTION FORCEPS WITH POINTS RACHET HANDLE WAS BROKEN IN TWO PIECES. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET 174MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368627 REDUCTION FORCEPS WITH POINTS RATCHET 174MM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.94 T160066 10886982203137

    Patients

    Seq Age Sex Outcome Treatment
    1