BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 3999780 · Received August 11, 2014

    Report

    Report Number
    1719045-2014-10366
    Event Type
    Injury
    Date Received
    August 11, 2014
    Report Date
    July 16, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: HWC. ORIGINAL IMPLANT DATE REPORTED ONLY AS (B)(6) 2005. USED BECAUSE THIS DEVICE IS DWELLING IN THE AREA OF THE REPORTED EVENT IT CANNOT BE DISASSOCIATED FROM THE REPORTED ADVERSE EVENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT IT REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 4885099 OF 11.0MM TI HELICAL BLADE 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 (4842753) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. 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 A PREVIOUSLY IMPLANTED TROCHANTERIC FIXATION NAIL, HELICAL BLADE AND LOCKING SCREW WERE REVISED TO A TOTAL HIP REPLACEMENT. A GREATER THAN 30 MINUTE SURGICAL DELAY WAS REPORTED DUE TO DIFFICULTY IN REMOVING THE DISTAL LOCKING SCREW, THE RECESS STRIPPED UPON REMOVAL REQUIRING THE USE OF A SCREW REMOVAL SET. THE SCREW WAS EVENTUALLY REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM TO THE PATIENT. THIS IS REPORT 1 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477197 11.0MM TI HELICAL BLADE 100MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES MONUMENT 4885099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention