BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 14396303 · Received May 13, 2022

    Report

    Report Number
    2939274-2022-01750
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 17, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982188779
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. 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.

    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. H3, H4, H6: PART 314.291, LOT 10-3418: RELEASE TO WAREHOUSE DATE: NOVEMBER 22, 2010. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS (NCR'S) GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DURING A RETROGRADE FEMORAL NAIL, THEY WENT TO USE THE COLLINEAR CLAMP TO AID US IN OUR REDUCTION AND THE TENSIONING GUN WOULD NOT HOLD TENSION. THE REPAIR TECHNICIAN REPORTED MISSING SYNTHETIC SCREEN AND RELEASE PLATE SPRING. MISSING PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS MISSING PARTS. THE EVALUATION WAS CONFIRMED. 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 INTRAOPERATIVELY ON (B)(6), 2022, DURING A RETROGRADE FEMORAL NAIL, THEY WENT TO USE THE COLLINEAR CLAMP TO AID US IN OUR REDUCTION AND THE TENSIONING GUN WOULD NOT HOLD TENSION. THERE WAS 20 MINS OF SURGERY DELAYED DUE TO THE REPORTED EVENT. THEY HAD TO USE A DIFFERENT CLAMP AND MAKE BIGGER INCISION TO AID IN THEIR REDUCTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT OUTCOME WAS UNKNOWN. OTHER MEDICAL INTERVENTION REQUIRED WAS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A SLIDING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113600 SLIDING MECHANISM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.291 10-3418 10886982188779

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown