BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8466767 · Received March 29, 2019

    Report

    Report Number
    2939274-2019-57182
    Event Type
    Injury
    Date Received
    March 29, 2019
    Report Date
    March 5, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982096685
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 LOT MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 04-MAY-2017, EXPIRATION DATE: 31-MAR-2027, PART #: 04.037.160S, LOT #: H356290 (STERILE) - 11MM/130 DEG TI CANN TFNA 400MM / RIGHT - STERILE. LOT QUANTITY: (B)(4). WORK ORDER TRAVELER WAS PROCESSED USING PLANNED NR NR-0060697 AT OP 160 FINAL INSPECTION. THIS PLANNED NC WILL ALLOW OPERATORS TO NO LONGER MEASURE THE NOTCH DEPTH FEATURE AT FINAL INSPECTION. THIS WAS DUE TO THE GAGE DAMAGING THE SPRING TABS ON THE PARTS WHEN USED AT FINAL INSPECTION. THE NOTCH DEPTH WILL CONTINUE TO BE MEASURED WITH A 100% INSPECTION FREQUENCY AT MILL ID. OPERATORS WILL LINE THROUGH AND N/A THE NOTCH DEPTH INSPECTION ITEM ON THE INSPECTION SHEET AND CITE THIS NONCONFORMANCE NUMBER ON THE INSPECTION SHEET. INSPECTION SHEET, IN PROCESS / INSPECT DIMENSIONAL / FINAL NS063045 REV J RECORDED NR-0060697 AT OP 160 FINAL INSPECTION FOR NOTCH DEPTH. THIS PLANNED NR WOULD NOT HAVE CONTRIBUTED TO THE COMPLAINT CONDITION BECAUSE IT ONLY REMOVES AN INSPECTION AT FINAL THAT IS ALREADY BEING PERFORMED AT 100% ON AN EARLIER OPERATION. THUS, THIS WOULD NOT IMPACT THE FINAL ACCEPTED PRODUCT. ONE PIECE WAS SCRAPPED IN CELL AT OP #20, MILL ID, FOR A SURFACE FINISH FAILURE. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION NS067861 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF REV C WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN 13697 SUPPLIED BY EES (ALBUQUERQUE) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL 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: 04.037.942.2 - LOCK PRONG, 130 DEGREE, TFNA BP-55, LOT NUMBER: L367724, LOT QUANTITY: (B)(4). PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55, LOT NUMBER: H249483, LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION NS062851 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD SUPPLIED BY SMALLEY DATED 24-FEB-2017 WAS REVIEWED AND DETERMINED TO BE CONFORMING. PART 04.037.912.3 - TFNA LOCK DRIVE BP-58, LOT NUMBER: H323714, LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET NS062925 REV D MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127 ¿ TIMOAGRI16.00 BP-80, LOT NUMBER: H201580, LOT QUANTITY: (B)(4). CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS PMD, INC DATED 14-SEP-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. NR-0051790 WAS INITIATED FOR OUTER DIAMETER BEING OVER SPECIFICATION OF 16.00 MAX. DIAMETER WAS FOUND TO BE 15.988-16.007. THE DISPOSITION OF THE NR WAS ¿USE AS IS¿ BECAUSE THE SLIGHTLY OVERSIZED CONDITION WOULD NOT AFFECT THE FINAL DIMENSIONS OF THE PRODUCT SINCE MATERIAL IS REMOVED DURING MACHINING AND DOES NOT AFFECT THE PHYSICAL PROPERTIES OF THE RAW MATERIAL. LOT SUMMARY REPORT DATED 07-DEC-2015 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 14-MAR-2019: THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT 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. 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 · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION OF OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH ANTEGRADE FEMORAL NAIL TO A RIGHT CLOSED COMMINUTED SUBTROCHANTERIC FEMUR FRACTURE. THE PATIENT HAD A NONUNION WHICH RESULTED IN A FAILED IMPLANT (PROXIMAL PORTION OF THE NAIL HAD FRACTURED) AS WELL AS PAIN AND INABILITY TO BEAR WEIGHT. THE PATIENT WAS INSERTED WITH A NEW IMPLANT. IT WAS SECURED WITH A COMPRESSION SCREW AND A LAG SCREW SET IN STATIC POSITION. TWO DISTAL INTERLOCKING SCREWS WERE ALSO PLACED INTO LOCKING POSITION. THE SURGEON REMOVED THE PROXIMAL PORTION OF THE NAIL WHICH HAD FRACTURED. THEN USED THE CROSS STARTING DEVICE TO REMOVE THE HELICAL BLADE THROUGH A SEPARATE INCISION, RECANNULATED THE PATIENTS REMAINING PORTIONS OF THE NAIL DISTALLY, REMOVED THE DISTAL INTERLOCKING SCREW, AND THEN USED A HOOK TO BALL TIP GUIDEWIRE TO HOOK ON TO THE DISTAL PORTION OF THE NAIL AND THEN MALLET IT OUT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE (PART 04.038.310S, LOT H383442, QUANTITY 1); UNKNOWN INTERLOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); 2.5MM REAMING ROD WITH BALL (PART # 351.706S, LOT # H238971, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5082249, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258095 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.160S H356290 10886982096685

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention