BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCR PERF L85 TAN

    MDR report key: 6678666 · Received June 29, 2017

    Report

    Report Number
    3003506883-2017-10124
    Event Type
    Injury
    Date Received
    June 29, 2017
    Report Date
    June 2, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: CONTACT PHONE NUMBER IS UNKNOWN. THERAPY DATE: UNKNOWN DATE IN (B)(6) 2017. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE PRODUCT CODE: KTT. (B)(4). CONCOMITANT REPORTED PARTS: THERAPY DATES: UNKNOWN: 2X GUIDE WIRE Ø 3.2MM, L 400MM (PART 357.399 LOT 9882940); 1X LOCKING SCREW Ø 5.0MM, L 36MM (PART 04.005.526S LOT 9905798); 1X TFNA FEMORAL NAIL Ø 10MM, L 235MM (PART 04.037.044S LOT 9970394). THE COMPLAINT INDICATED THAT THE SPIRAL BLADE MIGRATED POST-OP REQUIRING ADDITIONAL SURGICAL INTERVENTION. DURING THE REVISION PROCEDURE, THE SURGEON IDENTIFIED THE DAMAGED PAWL AFTER THE ROD WAS REMOVED. IN ADDITION, A SENTINEL EVENT WITH A SIMILAR EVENT WAS IDENTIFIED FOR THIS DEVICE THAT HAS RESULTED IN A SERIOUS INJURY OR DEATH IN THE PAST. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART # 04.038.185S LOT # 9970839, RELEASE TO WAREHOUSE DATE: 05 FEBRUARY 2016, EXPIRATION DATE: 01 JANUARY 2026, MANUFACTURING SITE: (B)(4). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 10.5MM TI TFNA FENESTRATED SCREW 85MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    AFTER THE RECEIPT OF THE ADDITIONAL INFORMATION, THE INITIALLY REPORTED CONCOMITANT DEVICE TFNA FEMORAL NAIL (PART 04.037.044S, LOT 9970394) IS NO LONGER CONSIDERED AS CONCOMITANT DEVICE AND IS DETERMINED AS THE REPORTABLE DEVICE. 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

    CLARIFICATION WAS RECEIVED: DURING THE REVISION SURGERY AFTER THE STEM WAS REMOVED, IT WAS NOTICED THAT THE LOCKING MECHANISM OF THE NAIL DAMAGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AT THE BEGINNING OF (B)(6) 2017 THE PATIENT HAD A SURGERY AND THE TRAUMA-TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS IMPLANTED. ON (B)(6) 2017 THE SPIRAL BLADE REACHED THE SUBCHONDRAL REGION AND AFTER REMOVAL OF THE ROD, IT WAS NOTICED THAT THE PAWL WAS DAMAGED. FOR THIS REASON THERE WAS NO PISTONING. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THE SURGERY WAS A REVISION SURGERY. DURING REVISION THE SURGEON NOTICED THE DAMAGED PAWL AFTER THE ROD WAS REMOVED. THE SURGERY WAS NOT PROLONGED. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PARTS: 2X GUIDE WIRE 3.2 MM, L 400MM (PART 357.399 LOT 9882940); 1X LOCKING SCREW 5.0 MM, L 36MM (PART 04.005.526S LOT 9905798); 1X TFNA FEMORAL NAIL 10MM, L 235MM (PART 04.037.044S LOT 9970394). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458325 TFNA SCR PERF L85 TAN APPLIANCE, FIXATION, NAIL HSB SYNTHES ELMIRA 9970839

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Required Intervention