BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    MDR report key: 8343679 · Received February 15, 2019

    Report

    Report Number
    2939274-2019-56471
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 24, 2019
    Report Date
    January 24, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982201386
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. H11 CORRECTED DATA: B4, G4: THESE DATES WERE INADVERTENTLY REPORTED AS 1/25/2019 IN THE INITIAL REPORT. THE CORRECT DATE IS 1/24/2019. 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

    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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: H10, OMIT VERBIAGE: DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS FROM INITIAL MEDWATCH. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. SNYTHES REP: DEVICE HISTORY RECORDS: PART NUMBER: 398.41, SYNTHES LOT NUMBER: T933354, RELEASE TO WAREHOUSE DATE: 25-FEB-2009, MANUFACTURE SITE: (B)(4), PART EXPIRATION DATE: N/A, LIST OF NON-CONFORMANCE: N/A. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND IT'S SUBCOMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. TRACEABILITY TO THE RAW MATERIAL LOT NUMBER COULD NOT BE ESTABLISHED DURING THIS DHR REVIEW. NO NCRS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019 DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) HUMERUS, THE REDUCTION FORCEPS WITH POINTS BROAD-RATCHET AND TIP BROKE OFF IN BONE AND WAS RETRIEVED. NOTHING LEFT IN PATIENT. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE. FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137506 REDUCTION FORCEPS WITH POINTS BROAD-RATCHET FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC T933354 10886982201386

    Patients

    Seq Age Sex Outcome Treatment
    1