BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1

    MDR report key: 8650513 · Received May 29, 2019

    Report

    Report Number
    8030965-2019-64639
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    April 12, 2019
    Report Date
    April 30, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LRN
    UDI-DI
    07611819733121
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. COMMON DEVICE NAME: ADDITIONAL DEVICE PRODUCT CODE: HTY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 292.620S. LOT: 3L51497. MANUFACTURING SITE: SELZACH. SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG RELEASE TO WAREHOUSE DATE: 22. FEB. 2019. EXPIRY DATE: 01. FEB. 2029. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT 3L26861 IN BALSTHAL AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 292.620 WITH LOT 3L26861 WERE REVIEWED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. 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. H10 ADDITIONAL NARRATIVE: H11 (CORRECTED DATA): B1, B5, H1: THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. PEC AND PC CODES UPDATED AS THIS IS A DUPLICATE COMPLAINT. REFER TO (B)(4). (THIS REPORT IS NOW NON-REPORTABLE.) 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. G4: THE INCORRECT G4 DATE WAS INADVERTENTLY UTILIZED IN FOLLOW-UP-1 MEDWATCH. THE CORRECT DATE IS JULY 10, 2019. 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

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE ANKLE ON (B)(6) 2019, THE 1.25 MM GUIDE WIRE WAS BROKEN WHILE ATTEMPTING TO DRILL THROUGH WITH AN UNKNOWN 2.7 MM CANNULATED DRILL BIT. THE SURGEON HAVE DECIDED NOT TO ATTEMPT TO RETRIEVE THE WIRE. AN UNKNOWN 3.5 MM CANNULATED SCREW WAS INSERTED OVER THE WIRE. THERE WAS NO INJURY OR PATIENT HARM REPORTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CANNULATED DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN 3.5 MM CANNULATED SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) GUIDEWIRE 1.25 W/THREAD-TIP W/TROCAR L1. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445058 GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1 WIRE, SURGICAL LRN OBERDORF SYNTHES PRODUKTIONS GMBH 3L51497 07611819733121

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - DRILL BITS: TRAUMA.| UNK - SCREWS: 3.5 MM CANNULATED.| UNK - DRILL BITS: TRAUMA| UNK - SCREWS: 3.5 MM CANNULATED