BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5794896 · Received July 14, 2016

    Report

    Report Number
    2520274-2016-13473
    Event Type
    Injury
    Date Received
    July 14, 2016
    Report Date
    June 30, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF NON-UNION IS UNKNOWN. REGARDING SCREW BREAKAGE: IT COULD NOT BE CONFIRMED IF THE SCREW BROKE PRE-REVISION OR DURING PLATE REMOVAL. HOWEVER, A FRAGMENT WAS LEFT IN THE PATIENT DURING THE REVISION ON (B)(6) 2016. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW WITH PARTIAL PART NUMBER 204.8XX. BASED UPON THE PARTIAL PART NUMBER, THE FOLLOWING INFORMATION IS LIKELY: THE 204.8XX: 3.5MM CORTEX SCREW SELF-TAPPING (RANGE FROM 10MM THROUGH 95MM). EITHER HWC (SCREW, FIXATION, BONE) OR HRS (PLATE, FIXATION, BONE) / HWC (SCREW, FIXATION, BONE). WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED APPROXIMATELY EIGHTEEN (18) YEARS AGO. A FRAGMENT WAS LEFT IN THE PATIENT DURING THE REVISION ON (B)(6) 2016. AS SUCH, AN EXPLANT DATE IS NOT APPLICABLE. ATTEMPTS ARE BEING MADE TO OBTAIN THE PRODUCT FOR MANUFACTURER REVIEW/INVESTIGATION. AT THIS TIME, IT IS UNKNOWN IF THE PART WILL BE RETURNED. BASED UPON THE PARTIAL PART NUMBER (204.8XX), THE LIKE 510K NUMBERS ARE: K112583 OR K131186. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. 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 AN ULNA FRACTURE WAS ORIGINALLY TREATED ON AN UNKNOWN DATE EIGHTEEN (18) YEARS AGO WITH THE INSERTION OF A 3.5MM LIMITED CONTACT - DYNAMIC COMPRESSION PLATE (LC-DCP). DURING A CLINIC VISIT ON AN UNKNOWN POST-OPERATIVE DATE, X-RAY IMAGING REVEALED THAT THE PLATE HAD BROKEN. AS A RESULT OF THE BREAKAGE AND AN IDENTIFIED NON-UNION, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR REVISION ON (B)(6) 2016. THE BROKEN PLATE WAS SUCCESSFULLY REMOVED, BUT A PORTION OF ONE (1) 3.5MM CORTICAL SCREW WAS LEFT IN SITU. IT IS UNKNOWN IF THE SCREW BROKE DURING PLATE REMOVAL OR PRIOR TO THE REVISION ITSELF. THE PATIENT WAS THEN REVISED TO A 3.5MM LOCKING COMPRESSION PLATE (LCP) WITH BONE GRAFT FROM A REAMER/IRRIGATOR/ASPIRATOR (RIA). THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF DELAY OR ADDITIONAL MEDICAL INTERVENTION. THE POST-OPERATIVE STATUS OF THE PATIENT WAS SAID TO BE STABLE. CONCOMITANT DEVICE(S) REPORTED: CORTICAL SCREWS (PART: 204.8XX / LOT: UNKNOWN / QUANTITY: 5). THIS REPORT IS FOR ONE (1) UNKNOWN 3.5MM CORTEX SCREW. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447964 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 204.8XX: UNKNOWN CORTICAL SCREWS (X5)