BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5096815 · Received September 23, 2015

    Report

    Report Number
    2520274-2015-16071
    Event Type
    Injury
    Date Received
    September 23, 2015
    Report Date
    September 14, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:(B)(6). DATE OF POST-OPERATIVE NON-UNION IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF INTACT SCREWS. ALL OF THE SCREWS LISTED BELOW HAVE BEEN IMPLANTED INTO THE PATIENT, BUT IT IS UNKNOWN WHICH REMAIN INTACT. PART: 201.768 / LOT: UNKNOWN (QTY: 1) - 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM ¿ HWC: SCREW, FIXATION, BONE - K112583. PART: 201.770 / LOT: UNKNOWN (QTY: 1) - 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM ¿ HWC: SCREW, FIXATION, BONE ¿ K112583. PART: 201.772 / LOT: UNKNOWN (QTY: 2) - 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM ¿ HWC: SCREW, FIXATION, BONE ¿ K112583. PART: 201.776 / LOT: UNKNOWN (QTY: 1) - 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM ¿ HWC: SCREW, FIXATION, BONE ¿ K112583. PART: 201.780 / LOT: UNKNOWN (QTY: 1) - 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM ¿ HWC: SCREW, FIXATION, BONE ¿ K112583. IT IS UNKNOWN AT THIS TIME IF THE DEVICES HAVE BEEN EXPLANTED OR IF THEY REMAIN IN THE PATIENT. PER FACILITY, THE COMPLAINANT PARTS BELONG TO THE PATIENT AND WILL NOT BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 WAS IMPLANTED WITH A 2.7MM VARIABLE ANGLE (VA) LOCKING XPLATE DURING A FIRST TARSAL-METATARSAL FUSION PROCEDURE ON OCTOBER 15, 2014. A BONE GRAFT WAS ALSO PERFORMED DURING THAT PROCEDURE. AT SOME POINT THEREAFTER, THE SURGEON NOTICED THAT (AN UNKNOWN QUANTITY OF UNKNOWN) 2.4MM CORTICAL SCREWS WERE BROKEN AND THE PATIENT HAD DEVELOPED A NON-UNION. AT THAT POINT, THE PATIENT WENT TO SEE ANOTHER DOCTOR. IT IS CURRENTLY UNKNOWN IF THE DEVICES WERE EXPLANTED OR IF THEY REMAIN IN THE PATIENT. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF INTACT SCREWS. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629176 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention