BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/2.0MM CUT-TO-LENGTH PLATE 50HOLES/300MM-VETERINARY

    MDR report key: 3082995 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11139
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    October 18, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A 510K#: DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE : IMPLANT DATE, UNKNOWN. PRODUCT DEVELOPMENT EVALUATION REVEALS, THAT THE PRODUCT THAT HAS BEEN RETURNED DOES NOT CORRELATE WITH PRODUCT NUMBER. IN FACT, BASED ON WIDTH AND THICKNESS MEASUREMENTS TAKEN ON THE RETURNED PLATE, IT DOES NOT CORRELATE WITH A SYNTHES VET PRODUCT. THEREFORE, THIS COMPLAINT IS INVALID RELATION TO DESIGN. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. MANUFACTURING EVALUATION REPORTS THAT THE PART WAS RECEIVED AND THE PLATE IS CUT ON BOTH SIDES FOR LENGTH ADAPTION AND BROKEN AT THE MIDDLE OF THE SEVEN HOLES. NO IDENTIFICATION LIKE PART OR LOT NUMBER IS VISIBLE ON THE PLATE. THIS PLATE DOES NOT CORRESPOND WITH THE PART AS DESCRIBED IN THE COMPLAINT. THIS RETURNED PLATE IS COMPLETELY FLAT AND REPORTED SYNTHES PLATE IS A 1/3 TUBE DESIGN. ALSO THE DISTANCE BETWEEN THE HOLES IS NOT IDENTICAL. THIS PLATE IS UNKNOWN AND NO IDENTIFICATION IS POSSIBLE, WHICH MAKES AN EVALUATION NOT POSSIBLE. THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PLATE BROKE POST-OPERATIVELY. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. PATIENT FRACTURE DID NOT HEAL, PATIENT WAS REVISED TO A DIFFERENT PLATE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184880 2.7MM/2.0MM CUT-TO-LENGTH PLATE 50HOLES/300MM-VETERINARY HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention