BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 9842593 · Received March 17, 2020

    Report

    Report Number
    8030965-2020-01997
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    September 1, 2006
    Report Date
    March 4, 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. 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

    THIS REPORT IS FOR AN UNKNOWN AO CANNULATED 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. 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: DINAH AF, VICKERS RH (2007), SMOKING INCREASES FAILURE RATE OF OPERATION FOR ESTABLISHED NON-UNION OF THE SCAPHOID BONE, INTERNATIONAL ORTHOPAEDICS (SICOT), VOLUME 31, PAGE 503-505, (UNITED KINGDOM). THE AIM OF THE STUDY WAS TO INVESTIGATE THE EFFECT OF SMOKING ON THE OPERATIVE TREATMENT OF ESTABLISHED NONUNION OF THE CARPAL SCAPHOID. BETWEEN 1992 AND 2003, 34 PATIENTS WHO UNDERWENT SURGERY FOR SCAPHOID NONUNION WERE INCLUDED IN THE STUDY. THE MEAN AGE 26.8 YEARS (RANGE 13.4-52.9 YEARS). THERE WERE ONLY 2 FEMALE PATIENTS IN THE GROUP. THERE WERE 37 OPERATIONS PERFORMED ON 34 PATIENTS, WITH 2 PATIENTS HAVING REPEAT PROCEDURES (AFTER FAILURE OF INITIAL SURGERY) AND 1 PATIENT HAVING BILATERAL OPERATIONS. OF THE 35 OPERATIONS USING SCREW FIXATION, AN UNKNOWN AO CANNULATED SCREW WAS IMPLANTED IN 25 PATIENTS AND THE REMAINING 10 PATIENTS WERE IMPLANTED WITH A COMPETITOR¿S DEVICE. ALL PATIENTS WERE PLACED IN A BELOW ELBOW CAST POST-OPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: (SMOKERS): 12 PATIENTS HAD NON-UNION. (NON-SMOKERS): 3 PATIENTS HAD NON-UNION. THIS REPORT IS FOR AN UNKNOWN AO CANNULATED SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307771 UNK - SCREWS: CANNULATED SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention