BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE

    MDR report key: 6297240 · Received February 2, 2017

    Report

    Report Number
    1719045-2017-10070
    Event Type
    Injury
    Date Received
    February 2, 2017
    Report Date
    January 11, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K092646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). ORIGINAL IMPLANT DATE UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR: PART# 04.032.100S, LOT# 7844477. MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: 12-NOV-2014. EXPIRATION DATE: 31-OCT-2024. PART #: 04.032.100S, LOT#: 7844477 (STERILE) - 11.0MM TI TROCH FIXATION NAIL SCREW/100MM-STERILE. QUANTITY 12. 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. 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

    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 REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, FOR A BROKEN LAG SCREW. THE REPORTER STATES THAT HE SAW AN X-RAY THAT SHOWED A TFN WITH A LAG SCREW THAT APPEARED TO BE BROKEN AT THE BASE. THE PATIENT IS BEING REVISED TO A HIP HEMIARTHROPLASTY. THERE IS 1 DEVICE IN THIS COMPLAINT. CONCOMITANT DEVICES REPORTED: NAIL (PART# UNKNOWN; LOT# UNKNOWN, QUANTITY 1) K-WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81711 11.0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7844477

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention DEVICES REPORTED: NAIL (PART & LOT UNK, QTY 1