BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER

    MDR report key: 6390040 · Received March 8, 2017

    Report

    Report Number
    1719045-2017-10208
    Event Type
    Injury
    Date Received
    March 8, 2017
    Report Date
    February 14, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). ORIGINAL IMPLANT DATE IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: (B)(4). MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: 01- NOV-2012. EXPIRATION DATE: 30 SEP -2021. P/N 456.363S, LOT #7057426 (7069695) (STERILE) -- 10MM/130 DEGREE TITANIUM (TI) CANNULATED TFN 420MM/LEFT STERILE . QUANTITY 6. WORK ORDER (B)(4) WAS RELEASED ON (B)(6) 2012. RAW MATERIAL LOT NO: 6950510 WAS RECEIVED FROM SUPPLIER ATI ALVAC. COMPONENTS REVIEWED: TROCHANTERIC FIXATION NAIL PART: 456.314.3, LOT 6977185. TROCHANTERIC FIXATION NAIL PART: 456.315.2, LOT 7051676. RAW MATERIAL LOT 6950510, INSPECTION SHEET FOR FINAL INSPECTION: (B)(4) MEET 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 THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SCN (B)(4) ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING." 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 REVISION SURGERY ON AN (B)(6) 2017 DUE TO A NON-UNION. NO INFORMATION WAS PROVIDED ON WHETHER THE PATIENT HAD SYMPTOMS RELATED TO THE NON-UNION OR HOW IT WAS DIAGNOSED; THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL SYSTEM (TFN) NAIL, BLADE AND TWO SCREWS ON AN UNKNOWN DATE. THESE DEVICES WERE REMOVED DURING THE REVISION AND THE PATIENT WAS REVISED WITH A SYNTHES TFN HIP NAIL. THERE WAS NO SURGICAL DELAY. NO INFORMATION WAS PROVIDED ON PATIENT OUTCOME. THIS COMPLAINT INVOLVES 4 DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170651 10MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER ROD, FIXATION, BONE HSB SYNTHES MONUMENT 7057426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention