BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM

    MDR report key: 7489002 · Received May 4, 2018

    Report

    Report Number
    2939274-2018-52043
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 12, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982201355
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH 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. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 398.40, LOT# T153783. MANUFACTURING LOCATION: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: JUL 21, 2017. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE DEVICE WAS RETURNED WITH ONE OF THE FORCEPS TIPS BROKEN OFF. THE BROKEN FRAGMENT WAS NOT RETURNED TO CUSTOMER QUALITY. THE OVERALL BALANCE OF THE DEVICE, INCLUDING THE RATCHETING MECHANISM LOOKS GOOD IN CONDITION WITH MINOR SIGNS OF WEAR WHICH DOES NOT IMPACT DEVICE FUNCTIONALITY. FORCEPS ASSEMBLY DRAWING WAS REVIEWED DURING THIS INVESTIGATION. THE DIAMETER OF THE RIGHT JAW FEATURE AT THE LOCATION OF THE BREAKAGE MEASURED Ø2.37MM (CA592) THAT FALLS WITHIN SPECIFICATION OF Ø2.4 MM +/- 0.2 PER RIGHT ARM COMPONENT DRAWING. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT UNINTENDED FORCES ENCOUNTERED DURING DEVICE USAGE OR HANDLING COULD HAVE LED TO COMPLAINT CONDITION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    PATIENT OUTCOME WAS REPORTED AS GOOD.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS REVIEW NOT AVAILABLE TO REPORT AT THIS TIME. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 WHILE REMOVING THE FORCEPS AFTER REDUCING THE FRACTURE SITE FOR A MIDSHAFT FRACTURE; THE TIP OF THE FORCEPS BROKE OFF. THE BROKEN TIP LANDED ON THE FLOOR AND DID NOT ENTER THE PATIENT. THE TIP WAS DISCARDED BY THE HOSPITAL. THE TIBIAL NAIL HAD ALREADY BEEN SUCCESSFULLY INSERTED WITHOUT ISSUE AT THE TIME THE FORCEPS WERE BEING REMOVED. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS STANDARD FOR THE PROCEDURE WERE TAKEN AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330485 REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 398.40 T153783 10886982201355

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR