BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5035587 · Received August 27, 2015

    Report

    Report Number
    2520274-2015-15542
    Event Type
    Injury
    Date Received
    August 27, 2015
    Report Date
    August 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS (B)(6). EXACT PATIENT WEIGHT WAS REPORTED AS (B)(6). DATE OF POST-OPERATIVE NON-UNION AND PAIN IS UNKNOWN. THIS REPORT IS FOR FOUR (4) UNKNOWN SCREWS WITH A PARTIAL PART NUMBER OF 04.005.5XX REPORTED. THE ORIGINAL IMPLANT PROCEDURE TOOK PLACE ON AN UNKNOWN DATE IN (B)(6) 2014. PER FACILITY, THE COMPLAINANT PARTS WERE RETURNED TO THE PATIENT AND ARE NOT AVAILABLE FOR INVESTIGATION. BASED UPON THE PARTIAL PART NUMBER, THE LIKELY 510K NUMBER IS K000089 AND THEREFORE HAS BEEN REPORTED IN THE ASSOCIATED FIELD. 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 A PATIENT WENT IN FOR A REVISION PROCEDURE ON (B)(6) 2015 DUE TO A NON-UNION OF THE DISTAL TIBIA. THE SURGEON REMOVED THE NAIL THAT WAS REAMED WITH A REAMING/IRRIGATION/ASPIRATOR (RIA) AND IMPLANTED AN EX-TIBIA NAIL (12 X 375MM) AND FIBLIA PLATE. THE SURGEON COLLECTED BONE GRAFT, PACKED THE FRACTURE WITH THE BONE GRAFT, AND EXCHANGED THE NAIL. THE SURGEON HAD NO TROUBLE INSERTING THE NEW NAIL OR THE NEW LOCKING SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO REPORTED TIME DELAY. THE PATIENT STATUS/OUTCOME IS UNKNOWN. THIS REPORT IS FOR FOUR (4) UNKNOWN SCREWS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567570 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention