BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8686355 · Received June 11, 2019

    Report

    Report Number
    8030965-2019-65167
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 HISTORY LOT THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY PART: 412.826S, LOT: 8997538, MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 02.JUNE 2014, EXPIRY DATE: 01.MAY 2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN GRENCHEN. PART: 412.826, LOT: 8992224, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 17.MAY 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI 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. (B)(4). 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) VOLAR RIM DISTAL RADIUS PLATE ON (B)(6) 2019, A 26MM TITANIUM (TI) LOCKING SCREW WAS USED TO FIX THE MOST DISTAL HOLE OF THE PLATE IN THE ULNA SIDE. SUPPOSEDLY, THE SURGEON WANTED TO USE A 30MM VARIABLE ANGLE LOCKING SCREW, BUT IT HAD NOT BEEN PREPARED FOR THE SURGERY. MOREOVER, THE LONGEST SCREWS IN THE SET WHICH HAD BEEN PREPARED FOR THE SURGERY WERE 26MM VA LOCKING SCREW. THE SURGEON DRILLED TO THE MOST DISTAL ULNA SIDE IN THE NEAR FIXED STATE USING THE VA SLEEVE IN A SITUATION WHERE TWO (2) 26MM VA LOCKING SCREWS HAD ALREADY BEEN USED. THE SURGEON DIDN'T WANT TO USE ANOTHER VA SCREW 26MM, SO INSERTED THE TI LOCKING 26 MM WITHOUT HESITATION. THE SURGERY WAS COMPLETED UNDER THE CONDITION THAT THE PLATE COULD NOT BE FIXED COMPLETELY WITH THE TI LOCKING SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: VA-LCP VOLAR RIM DISTAL RADIUS PLATE (PART: 04.115.750S, LOT: 3L24009, QUANTITY: 1). THIS REPORT IS FOR AN UNKNOWN 30MM LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482667 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VA-LCP VOLAR RIM DIST-RAD-PL2.4 R SHAFT| VA-LCP VOLAR RIM DIST-RAD-PL2.4 R SHAFT