BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM

    MDR report key: 8720074 · Received June 20, 2019

    Report

    Report Number
    2939274-2019-58804
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Report Date
    May 24, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXT
    UDI-DI
    1088698218080
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 292.68, LOT NUMBER: H840955, PART MANUFACTURING DATE: 01 MARCH 2019, MANUFACTURING SITE: ELMIRA, PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT H840955 OF THREADED GUIDE WIRES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT H699769 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION ONE PART WAS RECEIVED IN ITS SEALED PACKAGING. THE PACKAGE CONSISTS OF A TUBE CONTAINING A SINGLE PART, AND THE TUBE WAS CONTAINED IN A SEALED, LABELLED BAG. THE LABEL IDENTIFIES THE PART AS A 2.8 MM THREADED GUIDE WIRE ¿ TROCAR POINT 300 MM (PART NUMBER 292.68) FROM LOT H840955. THE RECEIVED PART WAS NOTICEABLY BENT AROUND THE MIDDLE OF ITS LENGTH. THE TUBE WAS CREASED AT ROUGHLY THE SAME LOCATION AS THE BEND IN THE PART. THE THREADED END OF THE PART HAS PIERCED THE END OF THE TUBE, AND BETWEEN A QUARTER AND A THIRD OF THE LENGTH OF THE THREADS PROTRUDES THROUGH THE HOLE. THE NON-THREADED END OF THE PART WAS PRESSED AGAINST THE OTHER END OF THE TUBE, CAUSING A VISIBLE ¿DENT¿, BUT NOT TO THE EXTENT THAT THERE WAS A HOLE. THE OUTER BAG AND LABEL ARE LARGELY UNDAMAGED, EXCEPT THAT THERE ARE SOME MARKS IN THE BAG NEAR THE PROTRUDING END OF THE PART THAT APPEAR TO BE FROM THE TROCAR POINT OF THE PART POKING INTO IT. IN ORDER TO INVESTIGATE THE COMPLAINT CONDITION, THE PART HAD TO BE REMOVED FROM ITS PACKAGING. DIMENSIONAL INSPECTION: FEATURES RELEVANT TO THE COMPLAINT CONDITION AND TO THE IDENTIFICATION OF THE PART WERE INSPECTED. FEATURE: CHECK PART SHAPE MEASURING DEVICE: VISUAL RESULT: FAIL ¿ PART WAS BENT FEATURE: 1 (OVERALL LENGTH) RESULT: COULD NOT BE OBTAINED ¿ PART WAS BENT FEATURE: 11 (SHAFT DIAMETER) RESULT: PASSED FEATURE: COSMETICS SPECIFICATION: COSMETICS ACCEPTABLE MEASURING DEVICE: VISUAL RESULT: FAIL ¿ PART WAS BENT DOCUMENTATION/SPECIFICATION REVIEW: RELEVANT DRAWING WAS REVIEWED DURING INVESTIGATION. NO DESIGN ISSUES RELEVANT TO THE COMPLAINT CONDITION WERE OBSERVED. MANUFACTURING RECORD EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT WAS CONFIRMED WITH INVESTIGATION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION APPEARS TO BE THE RESULT OF IMPROPER PRODUCT HANDLING AFTER THE PARTS LEFT THE MANUFACTURING FACILITY. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FACILITY RECEIVED THE ORDER, ONE (1) OF THE THREADED GUIDE WIRE-TROCAR POINT WAS BEND DURING SHIPPING. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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 FACILITY RECEIVED ONE (1) THREADED GUIDE WIRE-TROCAR POINT THAT WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. 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
    512039 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM LXT WRIGHTS LANE SYNTHES USA PRODUCTS LLC H840955 1088698218080

    Patients

    Seq Age Sex Outcome Treatment
    1