BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8492504 · Received April 8, 2019

    Report

    Report Number
    2939274-2019-57358
    Event Type
    Injury
    Date Received
    April 8, 2019
    Report Date
    March 14, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982096692
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. 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. DEVICE HISTORY LOT. MANUFACTURING DATE: 11-JUL-2018, EXPIRATION DATE: 31-MAY-2028, PART NUMBER: 04.037.161S, 11MM/130 DEG TI CANN TFNA 400MM / LEFT ¿ STERILE, LOT NUMBER: H677630 (STERILE). 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. COMPONENT PARTS REVIEWED: PART NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE, TFNA BP55, LOT NUMBER: L894350 / L910462. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED BP55, LOT NUMBER: H571503. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE BP58, LOT NUMBER: H671543 / H645420. PART NUMBER: 21127, TIMOAGRI16.00 BP80, LOT NUMBER: H258444. 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. 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

    THIS (B)(4) CAPTURES THE POST-OPERATIVE EVENT WHILE (B)(4) WAS CREATED TO CAPTURE THE INTRA-OPERATIVE EVENT.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MANUFACTURING DATE: JULY 11, 2018; EXPIRATION DATE: MAY 31, 2028; PART: 04.037.161S, 11MM/130 DEG TI CANN TFNA 400MM / LEFT ¿ STERILE; LOT: H677630 (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 INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. STERILIZATION CONTROL NUMBER (SCN) 15211 SUPPLIED BY EES (ALBUQUERQUE) WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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. COMPONENT PARTS REVIEWED: PART: 04.037.942.2, LOCK PRONG, 130 DEGREE, TFNA BP55; LOT: L894350 QUANTITY 3 / L910462 QUANTITY 3; LOT QUANTITY: 191 TOTAL / 96 (L894350) AND 95 (L910462). PURCHASED FINISHED GOODS TRAVELERS MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 04.037.912.4, WAVE SPRING, SHIM ENDED BP55; LOT: H571503; LOT QUANTITY: 1,000. 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) WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART: 04.037.912.3, TFNA LOCK DRIVE BP58; LOT: H671543 QUANTITY 1 / H645420 QUANTITY 5; LOT QUANTITY: 160 TOTAL / 80 (H671543) AND 80 (H645420). WORK ORDER TRAVELERS MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEETS MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 21127, TIMOAGRI16.00 BP80; LOT: H258444; LOT QUANTITY: 2,322 LBS. CERTIFICATE OF TEST SUPPLIED BY ATI SPECIALTY MATERIALS WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. (B)(4). 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 ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF A FEMUR FRACTURE DUE TO NONUNION, UPPER THIGH PAIN, DELAYED HEALING, AND SUBSEQUENT BREAKING OF ONE (1) TITANIUM LOCKING SCREW W/T25 STARDRIVE 2MM FOR INTRAMEDULLARY NAILS (IM). THE SCREW WAS ONE OF TWO DISTAL INTERLOCKING SCREWS, BUT THIS WAS THE ONLY SCREW THAT WAS BROKEN. THE PROXIMAL SEGMENT OF THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) NAIL WAS BROKEN ABOVE THE HELICAL BLADE/SCREW JUNCTION. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TITANIUM LOCKING SCREW W/T25 STARDRIVE 2MM FOR IM (PART: 04.005.532, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287058 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.161S H677630 10886982096692

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention