BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE

    MDR report key: 6824396 · Received August 28, 2017

    Report

    Report Number
    1719045-2017-10848
    Event Type
    Injury
    Date Received
    August 28, 2017
    Report Date
    August 7, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF NON-UNION IS NOT KNOWN. UDI: (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. HOSPITAL CONTACT TELEPHONE: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW FOR PART #: 04.037.014S, LOT#: H107990 - 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE. QUANTITY 4. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 27-MAY-2016. EXPIRATION DATE: 31-MAY-2026. COMPONENT PARTS REVIEWED: PART 04.037.912.2 - LOCK PRONG, 125 DEGREE, TFNA LOT - 9929191. PART 04.037.912.4 - WAVE SPRING, SHIM ENDED LOT - 9850953. PART 04.037.912.3 - TFNA LOCK DRIVE LOT ¿ H092531. PART 21127 - RAW MATERIAL LOT, LOT - H036288. RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFIED TEST REPORT RECEIVED FROM (B)(4) MEET SPECIFICATION. CERTIFICATE OF TEST FOR TITANIUM INGOT RECEIVED FROM (B)(4), HOWMET CASTING & RAW MATERIAL RECEIVED/(B)(4) CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR TFNA ASSEMBLY INSPECTION AND INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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

    INVESTIGATION SUMMARY: BASED ON THE RECEIVED INFORMATION (X-RAYS AND/OR PICTURES) WE ARE ABLE TO CONFIRM A BROKEN NAIL. THE PRODUCT WAS NOT RETURNED AND, AN INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, 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. DCRM REVIEW -> DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT, WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF THIS COMPLAINT CONDITION. DEVICE 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE TO IMPLANT A TROCHANTERIC PROXIMAL FEMORAL NAIL-ADVANCED (TFNA) SHORT NAIL, HELICAL BLADE, AND LOCKING SCREW TO TREAT A TRANSVERSE SUB TROCHANTERIC FEMUR FRACTURE ON (B)(6) 2017. INITIAL PROCEDURE REPORTED AS ROUTINE EXCEPT FOR THE NEED TO REAM THE MEDULLARY CANAL TO 1.5MM IN ORDER TO ACCOMMODATE THE NAIL, WHICH IS UNUSUAL FOR A SHORT NAIL PROCEDURE. PATIENT WAS INSTRUCTED TO WEIGHT BEAR AS TOLERATED POST-OPERATIVELY. ON (B)(6) 2017, PATIENT PRESENTED WITH A NON-UNION AND BROKEN NAIL. THE NAIL WAS REPORTED BROKEN AT THE LEVEL OF THE DISTAL LOCKING SCREW. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED THE BROKEN NAIL. SYNREAM WAS USED TO REAM TO 12.5MM. IT IS REPORTED EXTRACTION OF THE BROKEN IMPLANTS WAS CHALLENGING DUE TO SIGNIFICANT VARUS COLLAPSE OF THE PROXIMAL SEGMENT AND BECAUSE THE NAIL WAS BROKEN INTO THREE (3) PIECES. INSERTION OF DEVICES WAS ALSO COMPOUNDED BY THE UNSTABLE TRANSVERSE FRACTURE PATTERN, AS WELL AS BONE LOSS/RESORPTION LATERAL AREA GREATER TROCHANTER AND MEDICAL AREA LESSER TROCHANTER. REVISION REQUIRED AN EXTENDED PROXIMAL INCISION TO PERMIT OPEN FRACTURE REDUCTION USING REDUCTION FORCEPS AND BONE HOOK. ALL IMPLANTS WERE REMOVED AND PATIENT WAS REVISED TO A LONG TFNA NAIL, HELICAL BLADE, AND DYNAMIC DISTAL LOCKING SCREW. CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE (04.038.385S, LOT H147866, QUANTITY 1), TFNA LOCKING SCREW (04.005.524, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM 125 DEGREE TFNA NAIL-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604153 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H107990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention