BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM-STERILE

    MDR report key: 3805741 · Received May 12, 2014

    Report

    Report Number
    3003506883-2014-10050
    Event Type
    Injury
    Date Received
    May 12, 2014
    Report Date
    April 15, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CALALOG NUMBER: ORIGINALLY REPORTED AS; 456.308 ON INITIAL MEDWATCH. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: HWC. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 7542007 OF 11.0MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (7100893) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REMOVAL OF TROCHANTERIC FIXATION NAIL (TFN) HELICAL BLADE ON THE ANKLE WAS PERFORMED. THE SURGEON INSERTED A SHORTER TFN SCREW DUE TO PATIENT PAIN, IRRITATION, AND DISCOMFORT. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283717 11.0MM TI HELICAL BLADE 100MM-STERILE ROD, FIXATION, INTRAMEDULLARY, SCREW, FIXATION, BONE HSB SYNTHES ELMIRA 7542007

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention