BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE

    MDR report key: 9011882 · Received September 12, 2019

    Report

    Report Number
    2939274-2019-60497
    Event Type
    Injury
    Date Received
    September 12, 2019
    Report Date
    August 14, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982097439
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. UPDATE CONCOMITANT PRODUCTS PROVIDED FOR REPORTING. 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

    (B)(6) 2019: UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN CLAMP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), HELICAL BLADE (PART #: 04.038.400S, LOT #: H771531), LOCKING SCREW (PART #: 458.946S, LOT #: 7781086) AND LOCKING SCREW (PART #: 458.950S, LOT #: H515126).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4): THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. AND FRACTURE DISPLACEMENT, LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTION, JOINT RANGE OF MOTION DECREASED, PAIN, SURGICAL INTERVENTION & MEDICAL DEVICE REMOVAL. A REVIEW OF THE DEVICE HISTORY RECORD: DEVICE HISTORY LOT. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 25-MAY-2018. EXPIRATION DATE: 30-APR-2028. PART NUMBER: 04.037.263S, 12MM/130 DEG TI CANN TFNA 420MM/LEFT- STERILE. LOT NUMBER: H649278 (STERILE). LOT QUANTITY: (B)(4). 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 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 FOUND TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN (B)(4) SUPPLIED BY (B)(4) 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 PART(S) REVIEWED: PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55. LOT NUMBER: H529601. LOT QUANTITY: (B)(4). 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 RECEIVED FROM SMALLEY DATED 06-APR-2018 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE, TFNA, BP55. LOT NUMBER: L835715. LOT QUANTITY: (B)(4). PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58. LOT NUMBER: H582158. LOT QUANTITY: (B)(4). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMO AGRI 16.00, BP80. LOT NUMBER: H542396. LOT QUANTITY: (B)(4) LBS. CERTIFICATE OF ANALYSIS SUPPLIED BY (B)(4). DATED 18-DEC-2017 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 08-JAN-2018 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 28-AUG-2019: DHR 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/OR 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT A LEFT FEMUR REVISION AND REMOVAL DUE TO A PROGRESSIVE PAIN AND DECREASED MOVEMENT OF THE LEFT LEG. CONSULTING ORTHOPEDIST NOTED LEFT HIP PAIN STATUS POST ORIF WITH DISPLACEMENT OF FRACTURE FRAGMENTS AND LOSS OF FIXATION AND AN APPEARANCE OF A LARGE SPIKE OF BONE IN VASTUS LATERALIS WITH PAIN. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT HIP FRACTURE DUE TO FALL IN (B)(6) 2019. HOWEVER, TWO WEEKS AFTER AN IMPLANTATION, A LEFT HIP X-RAY WAS TAKEN ON UNKNOWN DATE SHOWED THAT THERE WAS AN IMPROVEMENT ANATOMIC ALIGNMENT BUT CONTINUED IRREGULARITY AND DEFORMITY IN THE REGION OF LEFT LESSER TROCHANTER BUT HARDWARE WERE INTACT. MOREOVER, A COMPUTER TOMOGRAPHY (CT) ON THE LEFT LOWER EXTREMITY SHOWED THAT THERE WAS A DYNAMIC HIP SCREW AND INTRAMEDULLARY ROD IN THE LEFT FEMUR AND A COMMINUTED INTERTROCHANTERIC FRACTURE THAT HAS BEEN REDUCED WITH THE HARDWARE THAT INVOLVED BOTH THE GREATER AND LESSER TROCHANTERS. THUS, PATIENT UNDERWENT LEFT FEMUR HARDWARE REMOVAL AND LEFT INTERTROCHANTERIC AND SUBTROCHANTERIC FEMUR REVISION WITH AN ORIF PROCEDURE. DURING REVISION, A TROCHANTERIC FEMORAL NAIL WAS REMOVED AND WAS APPEARED TO BE ROTATIONAL INSTABILITY PROXIMALLY WITH A LARGE CAVERNOUS PROXIMAL FEMUR AS SUCH INTERTAN WAS SELECTED FOR GREATER PROXIMAL CONTROL AND PURCHASE IN OSTEOPOROTIC BONE. AN UNKNOWN GUIDEWIRE WAS THEN PLACED ON THE INTRAMEDULLARY CANAL. SUBSEQUENTLY, THE FEMUR WAS REDUCED WITH CLAMP OPEN ACCESSORY INCISION. AN UNKNOWN STAINLESS STEEL WIRE WAS THEN TENSIONED AND CRIMPED TO MAINTAIN REDUCTION. THE PROXIMAL FEMUR WAS THEN SEQUENTIALLY REAMED UP TO A SIZE AND FEMORAL SHAFT WAS REAMED. AN UNKNOWN NAIL WAS THEN PACED DOWN THE INTRAMEDULLARY CANAL WHEREIN A TWO (2) UNKNOWN PROXIMAL SCREWS WERE PLACED ACHIEVING ROTATIONAL CONTROL PROXIMALLY AND TWO (2) UNKNOWN DISTAL INTERLOCKING SCREWS WERE PLACED ACHIEVING PURCHASE AND FIXATION. A FINAL FLUOROSCOPIC IMAGES WERE TAKEN AND REVEALED AN ANATOMICALLY REDUCED PROXIMAL FEMUR CONSTRUCT THAT WAS ROTATIONALLY STABLE. IT WAS REPORTED THAT A BROKEN LOCKING PRONG WAS DISCOVERED, HELICAL BLADE WAS SPINNING IN PROXIMAL NAIL WITH NO STABILITY OR CONTROL. SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY USING SMITH AND NEPHEW STAINLESS STEEL TITANIUM ALLOY INTERTAN. PATIENT OUTCOME WAS STABLE.CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDEWIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNKNOWN STAINLESS STEEL WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNKNOWN CLAMP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); REAMER (PART# 351.706S, LOT# H715802, QUANTITY 1); TFNA HELICAL BLADE ( PART# 04.038.400S, LOT# H771531, QUANTITY 1); LOCKING SCREW ( PART# 458.946S, LOT# 7781086, QUANTITY 1); LOCKING SCREW ( PART# 458.950S, LOT# H515126, QUANTITY 1).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
    807981 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.263S H649278 10886982097439

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE| 5.0MM TI LOCKING SCREW 46MM- FOR IM NAILS-STERILE| 5.0MM TI LOCKING SCREW 46MM- FOR IM NAILS-STERILE| 5.0MM TI LOCKING SCREW 50MM- FOR IM NAILS-STERILE| 5.0MM TI LOCKING SCREW 50MM- FOR IM NAILS-STERILE| TFNA FENESTRATED HELICAL BLADE 100MM - STERILE| TFNA FENESTRATED HELICAL BLADE 100MM - STERILE| UNK - CABLE/WIRE| UNK - EX-FIX CLAMPS| UNK - EX-FIX CLAMPS| UNK - GUIDE/COMPRESSION/K-WIRES| UNK - GUIDE/COMPRESSION/K-WIRES