BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/90MM-STERILE

    MDR report key: 4728278 · Received April 24, 2015

    Report

    Report Number
    3003506883-2015-10076
    Event Type
    Injury
    Date Received
    April 24, 2015
    Report Date
    April 9, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    PK964259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: JDO. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART MFG DATE: 03/31/2014. PART EXP. DATE: 02/2023, DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 7620998 OF DHS/DCS ONE-STEP LAG SCREW 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. DISPOSITION: UNCONFIRMED 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 HAD HIP FRACTURE SURGERY ON (B)(6) 2014. A DYNAMIC HIP SCREW (DHS) SYSTEM WAS IMPLANTED. INITIAL SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAYS. REDUCTION WAS SUCCESSFUL. IMAGING WAS TAKEN PERIODICALLY ON UNKNOWN DATES. PATIENT REPORTED PAIN ON UNKNOWN DATE. IMAGING TAKEN ON (B)(6) 2015 CONFIRMED A NON-UNION AND A BROKEN DHS/DCS ONE-STEP LAG SCREW. PATIENT WAS REVISED TO BIPOLAR HIP REPLACEMENT ON (B)(6) 2015. REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAYS. DEVICES AND IMAGING ARE NOT AVAILABLE FOR EVALUATION. THIS REPORT IS 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273385 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/90MM-STERILE APPLIANCE, FIXATION, NAIL, DEVICE KTT SYNTHES ELMIRA 7620998

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention