BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 6938169 · Received October 10, 2017

    Report

    Report Number
    1719045-2017-11045
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    September 24, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL PRODUCT CODE: HWC. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28-APR-2017, EXPIRATION DATE: 28-FEB-2026, PART #: 456.322S, LOT#: H329115 (STERILE) - 12 MM/130 DEG TI CANN TROCH FIXATION NAIL 170 MM - STERILE. QUANTITY 6. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: PART 456.314.3 - LOCK DRIVER TFN BP 55 LOT: H091659, PART 456.315.2 - 130 LOCK PRONG TFN BP 58 LOT: H314470. RAW MATERIAL PART NO: 21069 BP 80, 9833023 - RAW MATERIAL RECEIVED FROM SUPPLIER (B)(4). CERTIFICATE OF TEST RECEIVED FROM ATI MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A SHORT TROCHANTERIC FEMORAL NAIL (TFN) NAIL ON (B)(6) 2017 DUE TO A FRACTURE BENEATH THE SHORT TFN NAIL. THE PATIENT FELL POSTOPERATIVELY AND FRACTURED BENEATH THE NAIL. THE INTACT NAIL WAS EXCHANGED. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: HELICAL BLADE, DISTAL SCREW, LOCKING SCREW. THIS REPORT IS FOR ONE (1) 12 MM 130 DEGREE CANNULATED TFN NAIL 170 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716169 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H329115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention