BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHAFT FOR 90 SCREWDRIVER

    MDR report key: 11923956 · Received June 2, 2021

    Report

    Report Number
    9612488-2021-00002
    Event Type
    Injury
    Date Received
    June 2, 2021
    Report Date
    May 6, 2021
    Manufacturer
    SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    10887587013299
    PMA / PMN Number
    K082649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    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. THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE IMAGES LOCATED IN PC ATTACHMENT ¿(B)(4) ADDITIONAL INFORMATION WITH DEVICE PHOTO RECEIVED FROM HEALTHCARE PROFESSIONAL (B)(6) 2021". THE ATTACHMENT HAS IMAGES OF THE SHAFT FOR 90 SCREWDRIVER. SOME OF THE COMPONENTS OF THE DEVICES WERE NOT ASSEMBLED WITH IT AS THEY WERE BROKEN; THUS THE COMPLAINT IS CONFIRMED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED DURING PHOTO INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A MRE REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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 DEVICE PRODUCT CODES: DZI; DZJ. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A RE-OPEN SURGERY FOR THE REMOVAL OF REMAINED FOREIGN OBJECT. INITIALLY ON (B)(6) 2021, THE PATIENT UNDERWENT A RIB PLATING AND OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE TO TREAT ULNAR FRACTURE FROM A MOTOR VEHICLE ACCIDENT. DURING THE PROCEDURE THE DEVICE USED TO SECURE SCREWS CAME APART VS FAILED AT THE END OF THE PROCEDURE. X-RAY TAKEN AFTER CLOSURE OF PROCEDURE SHOWED A SIGNIFICANT FOREIGN OBJECT IN SUBCUTANEOUS TISSUE. PATIENT WAS NOT REMOVED FROM THE OPERATING ROOM AND WAS NOT EXTUBATED FROM THE INITIAL PROCEDURE. THIS REPORT CAPTURES THE RE-OPENING OF THE PATIENT FOR THE REMOVAL OF THE FOREIGN BODY OBJECT POST-OPERATIVELY, WHILE RELATED COMPLAINT (B)(4) (MW5100352) CAPTURES THE INTRA-OP EVENT WHERE THE DEVICE USED TO SECURE SCREWS CAME APART VS FAILED AT THE END OF THE RIB PLATING PROCEDURE. THIS REPORT IS FOR ONE (1) SHAFT FOR 90 SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822562 SHAFT FOR 90 SCREWDRIVER SCREWDRIVERS HXX SYNTHES PRODUKTIONS GMBH 03.505.003 10887587013299

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention