BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER

    MDR report key: 6969222 · Received October 23, 2017

    Report

    Report Number
    1719045-2017-11100
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 3, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HWC. (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART #: 456.419S, LOT#: 7959531 (STERILE) - 11 MM/130 DEG TI CANN TROCH FIXATION NAIL 380 MM/LEFT - STERILE. QUANTITY 6: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 01-APR-2015, EXPIRATION DATE: 28-FEB-2024: COMPONENT PARTS REVIEWED: 456.314.3 - TROCHANTERIC FIXATION NAIL LOCK DRIVER TFN, BP 55, LOT 7791058 , 456.315.2 - TROCHANTERIC FIXATION NAIL LOCK 130 DEG LOCK PRONG TFN, BP 58, 7955342 (4), 7955341 (2). 21069 - RAW MATERIAL LOT BP-80 LOT - 7735108 RECEIVED FROM SUPPLIER (B)(4). (B)(4) CERTIFICATE OF TEST MEETS SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR INSPECT DIMENSIONAL, FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. NO NON-CONFORMANCE REPORTS (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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2017 DUE TO A BROKEN TROCHANTERIC FIXATION NAIL (TFN). THE ORIGINAL PROCEDURE, A LEFT INTRAMEDULLARY (IM) NAIL WITH A TFN PROXIMAL FEMUR, WAS PERFORMED ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT EXPERIENCED HIP PAIN. THE PATIENT PRESENTED IN THE CLINIC AND X-RAYS SHOWED THAT THE FRACTURE WAS NOT HEALING, THE REDUCTION OF THE FRACTURE WAS LOST AND THE NAIL WAS BROKEN. THE HARDWARE REMOVAL INCLUDED: ONE BROKEN NAIL (BROKEN AT THE PROXIMAL END OF THE NAIL AT THE NAIL/BLADE JUNCTION AND THE SET SCREW WAS STILL ENGAGED WITH THE BLADE), ONE HELICAL BLADE (INTACT) AND TWO DISTAL LOCKING SCREWS (INTACT). THE ORIGINAL PLAN WAS TO CONVERT THE PATIENT TO A 95 DEGREE BLADE PLATE. THE SURGEON FELT THAT THERE WAS NOT ADEQUATE FEMORAL NECK LEFT. THE AREA WAS WASHED OUT AND CULTURES WERE TAKEN. THE SURGEON DECIDED TO AWAIT CULTURE RESULTS AND OBTAIN A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE FEMORAL NECK BEFORE PROCEEDING WITH ANY FUTURE TREATMENT PLAN. THE HARDWARE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART# 456.303, LOT# H384711, QUANTITY# 1), LOCKING SCREW, 42 MM (QUANTITY# 1), LOCKING SCREW, 48 MM (QUANTITY# 1). THIS REPORT IS FOR ONE (1) 11 MM/130 DEGREE TI CANNULATED TROCH FIXATION NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749945 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7959531

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HELICAL BLADE (PART# 456.303, LOT# H384711, QTY 1)| LOCKING SCREW, 42 MM (PART & LOT UNKNOWN, QTY 1)| LOCKING SCREW, 48 MM (PART & LOT UNKNOWN, QTY 1)