BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4862295 · Received June 23, 2015

    Report

    Report Number
    2520274-2015-14588
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INITIALS: (B)(6). PATIENT WEIGHT REPORTED AS (B)(6). THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING HIP OSTEOTOMY SURGERY, A SMALL HEXAGONAL SCREWDRIVER SHAFT TIP BROKE INSIDE THE SCREW. SURGEON TRIED RETRIEVING THE BROKEN TIP FOR FIVE MINUTES BUT HE WAS UNSUCCESSFUL AND BROKEN TIP REMAINED IN PATIENT. PATIENT/STATUS OUTCOME WAS FINE AND SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405290 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR