BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5763519 · Received June 30, 2016

    Report

    Report Number
    2520274-2016-13339
    Event Type
    Injury
    Date Received
    June 30, 2016
    Report Date
    June 10, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLEASE SEE USER FACILITY MEDWATCH REPORT (B)(4) ATTACHED TO THIS REPORT. PREVIOUSLY REPORTED INFORMATION WAS NOT DUPLICATED IF NOT NECESSARY. THIS REPORT IS FOR ONE UNKNOWN SCREW. PART NUMBER 211.028 WAS REPORTED; HOWEVER, THIS NUMBER IS INVALID. A LOT NUMBER WAS NOT REPORTED. OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    POTENTIAL PART NUMBER IDENTIFIED AS 02.211.028 OR ANOTHER NUMBER IN THAT PART FAMILY; LIKELY 510K IS K100776 A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLIANT IS CONFIRMED AS THE RETURNED SCREWS ARE ALL BROKEN. TWO ARE BROKEN MID THREAD AND THE OTHER IS BROKEN UNDER THE SCREW HEAD. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICES CONTRIBUTED TO THIS COMPLAINT. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RELEVANT TABULATED SCREW DRAWINGS WERE REVIEWED DURING THIS EVALUATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED BY SYNTHES CUSTOMER QUALITY ON JUNE 10, 2016. ADDITIONAL INFORMATION AND CLARIFICATION RECEIVED FROM THE USER FACILITY REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE IN (B)(6) 2016 DUE TO CONTINUED PAIN AND PROMINENT HARDWARE. DURING THE REVISION SURGERY ONE UNKNOWN PLATE AND THREE BROKEN SCREWS WERE EXPLANTED. THE THREE BROKEN SCREWS WERE LOCATED IN THE PROXIMAL PORTION OF THE PLATE. THE PATIENT ALSO HAD AN UNKNOWN QUANTITY OF UNKNOWN SCREWS, TWO UNKNOWN COMPETITOR K-WIRES, AND POSSIBLY OTHER UNKNOWN IMPLANTS WHICH MAY NOT HAVE BEEN EXPLANTED DURING THE REVISION SURGERY. THE PATIENT WAS INITIALLY IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF LEFT FIRST METATARSAL WAS PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2015. THIS REPORT IS FOR ONE UNKNOWN SCREW. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICES REPORTED: PLATE (PART AND LOT UNKNOWN, QUANTITY 1); SCREWS (PART AND LOT UNKNOWN, QUANTITY: UNKNOWN; K-WIRES (PART AND LOT UNKNOWN, QUANTITY 2); OTHER IMPLANTS (PART AND LOT UNKNOWN, QUANTITY: UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415649 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention