BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 9814024 · Received March 10, 2020

    Report

    Report Number
    8030965-2020-01784
    Event Type
    Injury
    Date Received
    March 10, 2020
    Report Date
    February 25, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6: PATIENT CODE 3191 IS USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN 6.5 MM CANNULATED AO SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: JONES, S., RAY, P., KUMAR, A. AND SWITH, T.W.D. (1999), ARTHRODESIS FOR FAILED ANKLE ARTHROPLASTY: A TECHNIQUE USING THE FIBULA AS AN AUTOGENEOUS BONE GRAFT, THE FOOT, VOL. 9, PAGES 142-144 (UNITED KINGDOM). THE AIM OF THIS STUDY IS TO REPORT A TECHNIQUE OF ANKLE ARTHRODESIS FOR FAILED TOTAL ANKLE ARTHROPLASTY USING THE DISTAL FIBULA AS AUTOGENOUS BONE GRAFT. A TOTAL OF 3 PATIENTS WERE TREATED WITH 2 6.5 MM CANNULATED AO SCREWS. THEY HAD AN AVERAGE FOLLOW-UP OF 1 YEAR. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD FEMALE PATIENT SHOWED RADIOLOGICAL UNION ONE YEAR AFTER ANKLE ARTHRODESIS. THE METALWORK WAS REMOVED DUE TO SUPERFICIAL SKIN IRRITATION. THERE HAD BEEN A PREVIOUS SUBTALAR FUSION. 1 PATIENT HAD 3 CM SHORTENING BUT HAS PROGRESSED WELL WITH A SHOE RAISE. 2 PATIENTS HAD METALWORK REMOVED BECAUSE OF SOFT TISSUE IRRITATION. 1 PATIENT STILL PREFERS TO USE ONE CRUTCH AND COMPLAINS OF OCCASIONAL DISCOMFORT. THIS REPORT IS FOR A 6.5 MM CANNULATED AO SCREW. IT CAPTURES THE REPORTED (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD METALWORK REMOVED DUE TO SUPERFICIAL SKIN IRRITATION. THIS IS REPORT 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274192 UNK - SCREWS: CANNULATED SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention