BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8506028 · Received April 11, 2019

    Report

    Report Number
    2939274-2019-57443
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 14, 2019
    Report Date
    March 14, 2019
    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
    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 HISTORY RECORDS: 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). LOT QUANTITY: 6. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. 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 NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE, TFNA BP55. LOT NUMBER: 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 NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED BP55. LOT NUMBER: 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 SMALLEY DATED 29-MAY-2018 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE BP58. LOT NUMBER: 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 NUMBER: 21127, TIMOAGRI16.00 BP80. LOT NUMBER: H258444. LOT QUANTITY: 2,322 LBS. CERTIFICATE OF TEST SUPPLIED BY ATI SPECIALTY MATERIALS, DATED 17-NOV-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 14-DEC-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 25-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. 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 (B)(6) 2019, THE SURGEON REMOVED THE RETAINED BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL USING THE NAIL EXTRACTOR BUT WAS NOT ABLE TO BE REMOVED INTRAOPERATIVELY, AND WAS IMMEDIATELY DISCARDED BECAUSE THE BROKEN NAIL WAS DANGEROUSLY SHARP. ALL IMPLANTS WERE SAFELY EXTRACTED. SURGEON WAS ALSO DIRECTLY REDUCING THE FRACTURE WITH A CABLE, HARVESTING BONE FROM THE FEMUR WITH RADIOIMMUNOASSAY (RIA), AND GRAFTING NON-UNION SITE WITH AUTOGRAFT AND ALLOGRAFT (VIVIGEN FORMABLE 5CC), AND FENESTRATED TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SCREW, AND TRAUMACEM WAS ALSO USED TO AUGMENT THE FIXATION IN THE FEMORAL HEAD. PATIENT HAD A REVERSE INTERTROCHANTERIC HIP FRACTURE OF LEFT HIP LAST FALL OF 2018. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN BUT WITH A PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 04.037.161S, LOT: H677630. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUL 11, 2018, EXPIRY DATE: MAY 31, 2028. 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. 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. 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 PATIENT HAD A REVERSE INTERTROCHANTERIC HIP FRACTURE OF LEFT HIP IN FALL OF 2018. 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). DURING THE SURGERY, THE SURGEON WAS TRYING TO REMOVE THE RETAINED BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL USING THE NAIL EXTRACTOR BUT WAS NOT ABLE TO BE REMOVED. ALL IMPLANTS WERE SAFELY EXTRACTED. SURGEON WAS ALSO DIRECTLY REDUCING THE FRACTURE WITH A CABLE, HARVESTING BONE FROM THE FEMUR WITH RADIOIMMUNOASSAY (RIA), AND GRAFTING NON-UNION SITE WITH AUTOGRAFT AND ALLOGRAFT (VIVIGEN FORMABLE 5CC). FENESTRATED TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SCREW, AND TRAUMACEM WAS ALSO USED TO AUGMENT THE FIXATION IN THE FEMORAL HEAD. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN BUT WITH A PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS: CABLE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299600 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 84 YR