BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM THREADED GUIDE WIRE 150MM

    MDR report key: 12037407 · Received June 21, 2021

    Report

    Report Number
    8030965-2021-05151
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 13, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    LRN
    UDI-DI
    07611819013841
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. D2B: ADDITIONAL DEVICE PRODUCT CODE: HTY. H6: CUSTOMER QUALITY INVESTIGATION: THE GUIDEWIRE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE IMAGES PROVIDED. UPON INSPECTING THE IMAGES PROVIDED, THE PART NUMBER AND THE LOT NUMBER CANNOT BE IDENTIFIED FROM THE DEVICE AND THE COMPLAINT CONDITION OF A BROKEN GUIDE WIRE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER PROVIDED DOES NOT MATCH THE PART NUMBER. CONCLUSION: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES, OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. 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 · 0

    THIS REPORT IS FOR ONE (1) 1.25MM THREADED GUIDE WIRE 150MM.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: COMPLAINANT DEVICE/PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTERS STATE: (B)(6). 510K): UNKNOWN, AS SPECIFIC LOT NUMBERS ARE UNKNOWN; DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 THE GUIDE WIRE BROKE IN THE REDUCTION TO PLACE THE CANNULATED SCREW. PRODUCT: 292.620, LOT: 2L71235. ONE PIN 1.25 IS BROKE AND REMAINS INSIDE THE PATIENT. PRODUCT: 292.620 BATCH: 2L71235. TWO PINS 1.25 ARE BENT. PRODUCT: 292.620 BATCH: 2L53848. ONE CANNULATED SCREW 4.0 L38 IS MISSING AND THERE IS AN ADDITIONAL WASHER, FOR A TOTAL OF THREE. ONE LOCKED SCREW L26, ONE CORTICAL SCREW L26 AND TWO CORTICAL SCREWS L30 ARE MISSING. THE TALUS PLATE IS MISSING CODE: LOT: H875290. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR THREE (3) OF THE 13 DEVICES. THIS REPORT IS FOR ONE (1) GUIDE-WIRE Ø1.25 W/THREAD-TIP W/TROCAR L1 THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929128 1.25MM THREADED GUIDE WIRE 150MM WIRE, SURGICAL LRN SYNTHES GMBH 2L71235 07611819013841

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1| GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1| GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1| TALUSPL 2.4 LOCKING SST| UNK - SCREWS: 4.0 MM CANNULATED| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: LOCKING| UNK - WASHERS