BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE

    MDR report key: 7794309 · Received August 17, 2018

    Report

    Report Number
    2939274-2018-53367
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    June 20, 2018
    Report Date
    June 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982096692
    PMA / PMN Number
    K160167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4) MANUFACTURING DATE: 14-AUG-2015 EXPIRATION DATE: 31-JUL-2025 PART #: 04.037.161S, 11MM/130 DEG TI CANN TFNA 400MM / LEFT - STERILE. LOT NUMBER: 9876630 (STERILE) LOT QUANTITY: 6 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL, MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, TFNA ASSEMBLY INSTRUCTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG WAS REVIEWED AND FOUND TO BE CONFORMING. PACKAGING BOM INDICATES THAT ALL PACKAGING USED MET CURRENT SPECIFICATIONS. (B)(4) SUPPLIED BY (B)(4) WAS REVIEWED AND FOUND TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: PART NUMBER: 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55 LOT NUMBER: 9375370 LOT QUANTITY: 96 PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT NUMBER: 7921038 LOT QUANTITY: 995 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD SUPPLIED BY (B)(4) DATED (B)(4) 2015 WAS REVIEWED AND FOUND TO BE CONFORMING. PART NUMBER: 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT NUMBER: 9852387 LOT QUANTITY: 80 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127 ¿ TIMOAGRI16.00 BP-80 LOT NUMBER: 7853398 CERTIFIED TEST REPORT RECEIVED FROM (B)(4) DATED (B)(4) 2014 WAS REVIEWED AND FOUND TO BE CONFORMING. CERTIFICATE OF TEST RECEIVED FROM HOWMET CASTINGS DATED (B)(4) 2014 WAS REVIEWED AND FOUND TO BE CONFORMING. LOT SUMMARY REPORT DATED (B)(4) 2014 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. COMPLAINT SUMMARY: THERE WERE MULTIPLE DEVICES WITH ISSUES IN THIS COMPLAINT. INITIALLY, THE NAIL WAS REPORTED AS A CONCOMITANT DEVICE HOWEVER DURING THE INVESTIGATION IT WAS NOTED THAT THE THREADS WERE DEFORMED. THE FLOW FOR BROKEN WAS SELECTED TO COMPLETE THIS INVESTIGATION. FLOW: BROKEN VISUAL INSPECTION: THE NAIL (PART 04.037.161S, LOT 9876630, MFG 14-AUG-2015) WAS RECEIVED AT US CQ WITH A BROKEN TANG. THE FRACTURE IS AT THE TRANSITION BETWEEN BODY OF THE NAIL AND PROXIMAL TANG. THERE WAS NO INITIAL COMPLAINT AGAINST THIS DEVICE, THE SALES CONSULTANT REPORTED THE DEVICE AS CONCOMITANT HOWEVER ON INSPECTION AT US CQ IT WAS NOTICED THAT THE TANG WAS BROKEN, THEREFOR THE COMPLAINT IS CONFIRMED. DIMENSIONAL INSPECTION DIMENSIONAL ANALYSIS COULD NOT BE COMPLETED AS THE TANG WAS BROKEN OFF AND NOT RETURNED. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWING(S) WAS REVIEWED: TABULATED TFNA, 11MM TI TFNA. DHR REVIEW SHOWED NO NCR¿S WERE GENERATED DURING PRODUCTION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE NAIL (PART 04.037.161S, LOT 9876630) WAS RECEIVED BROKEN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING REMOVAL. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF 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 · 1

    IT WAS REPORTED THAT UPON OPENING THE SET DURING A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) REMOVAL ON (B)(6) 2018, THE TIP OF THE HELICAL BLADE/SCREW EXTRACTOR WAS DISCOVERED TO BE BROKEN OFF AND COULD NOT BE USED TO REMOVE THE (TFNA) SCREW. THE INSERTION HANDLE WAS THEN CONNECTED WITH THE HELICAL BLADE/SCREW COUPLING SCREW TO THE (TFNA) SCREW IN AN ATTEMPT TO REMOVE THE (TFNA) SCREW. THE SCREW WAS FINALLY REMOVED, BUT THE SCREW INSERTER, COUPLING SCREW, AND (TFNA) SCREW WERE ALL DAMAGED IN THE PROCESS. THE HELICAL BLADE/SCREW COUPLING SCREW WON'T SLIDE IN, THE SCREW INSERTER WAS BENT AND THE TFNA SCREW PEELED OFF. IT WAS UNKNOWN WHEN THE HARDWARE WAS IMPLANTED. THE HARDWARE REMOVAL WAS SCHEDULED DUE TO THE PATIENT'S AGE. THERE WAS A 15 MINUTE SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORT: INSERTION HANDLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 11MM 130 DEGREE CANNULATED TFNA NAIL 400MM LEFT THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634337 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.161S 9876630 10886982096692

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR