BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR R SHAF

    MDR report key: 9182836 · Received October 11, 2019

    Report

    Report Number
    8030965-2019-69294
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    September 26, 2019
    Report Date
    September 26, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H3, H6: INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT , PART: 04.111.520S, LOT: L370512, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 25. APRIL 2017, EXPIRY DATE: 01. APRIL 2027. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE, BY NC-0063285 WERE 8 PIECES DETECTED OUT OF SPECIFICATION. AFTER RE-WORK WERE ALL PARTS RELEASED OF THIS LOT. 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 · 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

    ADDITIONAL PRO CODES: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL RADIUS FRACTURE WITH THE VA TWO-COLUMN VOLAR DISTAL RADIUS PLATE AND THE VA LOCKING SCREW IN QUESTION. DURING THE SURGERY, THE SURGEON ATTACHED THE VA SLEEVE TO THE VA HOLE BEFORE DRILLING. AFTER THAT, THE SURGEON TRIED TO INSERT THE VA LOCKING SCREW. DURING THE INSERTION OF THE SCREW, THE SCREW SLIPPED AND FAILED TO LOCK AS ITS HEAD CONTACTED THE PLATE. THE UNLOCKED SCREW WAS REMOVED, AND SURGEON REINSERTED ANOTHER SCREW WHICH COULD NOT BE LOCKED EITHER. IT WAS LEFT IN THE PATIENT UNLOCKED. LATTER ATTEMPTS WERE SUCCESSFUL. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER SHAFT (PART # / LOT # UNKNOWN; QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) VA-LCP-2-COLUMN DRP2.4 VOLAR NARR R SHAF. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975989 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR R SHAF PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L370512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - SCREWDRIVERS: SHAFTS