BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5450452 · Received February 22, 2016

    Report

    Report Number
    2520274-2016-11177
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    January 21, 2016
    Report Date
    February 2, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE INVOLVES A VETERINARY CASE. THE PATIENT IS A FOAL (HORSE); THEREFORE, NO PATIENT INFORMATION WILL BE REPORTED. THIS REPORT IS FOR TWO (2) UNKNOWN 4.5MM CORTEX SCREWS WITH POTENTIAL PART NUMBERS VS402.8XX OR 214.8XX, VS402.8XX ¿ 4.5MM CORTEX SCREW ¿ VET USE ONLY, 214.8XX ¿ 4.5MM CORTEX SCREW ¿ K112583 - HWC. PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING DEVICE(S) WERE RECEIVED: 4.5MM CORTEX SCREWS, SELF-TAPPING (POSSIBLY PART # VS402.8XX OR 214.8XX / LOT UNKNOWN) - QUANTITY: 2. TWO SCREWS WERE RECEIVED WITH THE HEADS BROKEN OFF THE SHAFTS. THE SHAFTS ARE BENT AND GOUGED, AND THE HEADS ARE SEVERELY DAMAGED IN THE FORM OF SCRATCHES, GOUGES, AND BURRS. THE SCREWS ARE 4.5MM CORTEX SCREWS, BUT THE EXACT PART NUMBERS ARE UNABLE TO BE DETERMINED DUE TO THE DAMAGE. THE EXACT CAUSE OF THE DAMAGE IS UNKNOWN, BUT THE BENDING WAS LIKELY THE RESULT OF EXCESSIVE STRAIN PLACED ON THE IMPLANTS DUE TO A NON-COMPLIANT PATIENT ((B)(6) FOAL). IT IS LIKELY THAT THIS WEAKENED THE SCREW AND THEN THE FORCE USED TO EXTRACT THE SCREWS CAUSED THE SCREW HEADS TO BREAK OFF. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE SCREWS ARE 4.5MM CORTEX SCREWS, BUT THE EXACT PART NUMBERS ARE UNABLE TO BE DETERMINED DUE TO THE DAMAGE. THE IMPLANTS COULD EITHER BE PART OF THE SCREW FAMILY VS402.8XX OR 214.8XX. AS SUCH, BOTH DRAWINGS FOR THE DEVICE FAMILIES WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGNS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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 (B)(6) FOAL (HORSE) UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016 DUE TO SCREW BENDING. DURING THE PROCEDURE, THE HEADS OF TWO (2) SCREWS POPPED OFF DURING EXTRACTION. THE HEADS AND SHAFTS WERE BOTH ABLE TO BE RETRIEVED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT OR DELAY. THIS REPORT WILL ADDRESS THE INTRA-OPERATIVE BREAKAGE OF THE SCREWS. THE POST-OPERATIVE BENDING WAS CAPTURED IN AND REPORTED UNDER (B)(4). THIS REPORT IS FOR TWO (2) UNKNOWN 4.5MM CORTEX SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109717 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1