BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 32MM

    MDR report key: 3910686 · Received July 2, 2014

    Report

    Report Number
    2520274-2014-12317
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.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

    DEVICE USED IN A VETERINARY CASE. NO PATIENT INFORMATION WILL BE REPORTED. 510K: DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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

    (B)(4). DATE RETURNED TO MANUFACTURER SHOULD BE 06/26/2014.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 PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THREE BROKEN 3.5MM SS LOCKING SCREWS WERE RECEIVED FOR EVALUATION. ALL THREE HEADS HAVE SHEARED OFF AT THE TRANSITION TO THE NECK. THE RELEVANT TABULATED PRODUCT DRAWING WAS REVIEWED DURING THIS EVALUATION WHICH NOTES THE LATEST RELEASED STANDARD PART NUMBER DRAWINGS FOR THE NON-VETERINARY EQUIVALENT SCREWS. THE SCREWS ARE MANUFACTURED FROM 316L STAINLESS STEEL WHICH IS A TYPICAL MATERIAL USED FOR IMPLANTABLE BONE SCREWS. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT. THIS COMPLAINT WAS MOST LIKELY CAUSED BY EARLY EXCESSIVE STRAIN BY THE CANINE PATIENT. 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 VETERINARY REVISION SURGERY TOOK PLACE DUE TO THREE BROKEN SCREWS AND THE PATIENT EXPERIENCING LAMENESS, AND SWELLING. THE SURGEON ORIGINALLY PERFORMED A TIBIAL PLATEAU LEVELING OSTEOTOMY PROCEDURE ON (B)(6) 2014. THE PATIENT WAS BROUGHT BACK TO THE SURGEON FOR LAMENESS AND SWELLING AT THE SURGICAL SITE ON (B)(6) 2014. THE SURGEON CONFIRMED VIA RADIOGRAPHS ON (B)(6) 2014 THAT THREE OF THE PROXIMAL LOCKING SCREWS WERE COMPLETELY BROKEN AT THE NECK OF EACH SCREW. THE SURGEON EXPLANTED ALL HARDWARE, WHICH INCLUDED, 1-TIBIAL PLATEAU LEVELING OSTEOTOMY PLATE, 3-LOCKING SCREWS, AND 3 CORTEX SCREWS. IT WAS REPORTED THAT THE PLATE AND CORTEX SCREWS WERE INTACT. THE SURGEON ELECTED TO IMPLANT A 3.5 MM BROAD PLATE USING FOUR 3.5 MM LOCKING SCREWS IN THE PROXIMAL HOLES AND FOUR 3.5 MM CORTEX SCREWS IN THE DISTAL HOLES AND SURGERY WAS SUCCESSFULLY COMPLETED. NO HUMAN PATIENT INVOLVED. THERE WAS NO REPORT OF A SURGICAL DELAY. THIS REPORT IS FOR 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386372 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 32MM SCREW, FIXATION, NAIL HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1