BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 14MM

    MDR report key: 15640210 · Received October 20, 2022

    Report

    Report Number
    8030965-2022-08523
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    September 29, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K141527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART: 04.130.214S, LOT: L896494, MANUFACTURING SITE: WERK GRENCHEN, SUPPLIER: NA, RELEASE TO WAREHOUSE DATE: 08 MAY 2018, EXPIRATION DATE: NA. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE VA LOCKSCR Ø1.5 SELF-TAP L14 TAN, P/N: 04.130.214S, EXHIBITS SIGNS OF NORMAL USE. NO SIGNIFICANT PRODUCT PROBLEMS WERE OBSERVED ON THE SURFACE OF THE DEVICE. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO NOT BEING APPLICABLE TO THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE VA LOCKSCR Ø1.5 SELF-TAP L14 TAN, P/N: 04.130.214S WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. 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 PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS 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. ADDITIONAL DEVICE PRODUCT CODES: HWC. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THERAPY DATE: (B)(6) 2022. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE DRILL BITS AND THE SCREWS FOR THE COMMINUTED FRACTURE OF THE PROXIMAL PHALANX AND THE INDEX PROXIMAL PHALANX. WHEN THE SURGEON DRILLED TO THE PLATE WITHOUT A DRILL SLEEVE, THE TIP OF THE DRILL BIT BROKE AND REMAINED IN THE PATIENT¿S BODY. IT TOOK APPROXIMATELY 30 MINUTES TO REMOVE THE BROKEN TIP. THE SURGEON DRILLED WITH A NEW DRILL BIT AND A DRILL SLEEVE, AND THE TIP OF THE DRILL BIT BROKE AND REMAINED IN THE PATIENT¿S BODY AGAIN. IT TOOK MORE THAN 30 MINUTES. BOTH DRILLS WERE BROKEN AT THE BORDER OF THE FLUTE. IT WAS CONFIRMED BY X-RAYS THAT THERE WERE NO BROKEN PIECES IN THE PATIENT¿S BODY. IN ADDITION, WHEN THE SURGEON WAS INSERTING THE SCREWS, THE SCREWS STOPPED IN THE MIDDLE OF THE ROAD DUE TO WRONG DIRECTION. ALTHOUGH THE SURGEON REMOVED THE SCREWS AND RE-INSERTED THEM SEVERAL TIMES, THE SCREW HEADS BROKE AND COULD NOT BE REMOVED. THEREFORE, THE SURGEON REMOVED THE SCREWS WITH A PLIER. IT WAS CONFIRMED BY X-RAYS THAT THERE WERE NO BROKEN SCREWS IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH TWO HOURS DELAY. THE OPERATION WAS SCHEDULED TO TAKE TWO HOURS; HOWEVER, IT TOOK FOUR HOURS. ACCORDING TO THE SURGEON, THE SCREWS DIRECTION MIGHT HAVE BEEN AT AN ANGLE TO THE DRILLED HOLE. THE SURGEON ALSO COMMENTED THAT HE TRIED TO INSERT THE SCREWS WITH A DRIVER FORCEFULLY ALTHOUGH THE PATIENT HAD GOOD BONE QUALITY WHICH MIGHT CAUSE THE EVENT. THIS REPORT INVOLVES ONE (1) 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 14MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495985 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 14MM SCREW, FIXATION, BONE HWC SYNTHES GMBH L896494

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CORTSCR Ø1.5 SELF-TAP L12 TAN| DRILL BIT Ø1.1 L70/39 F/CORE HOLE| DRILL BIT Ø1.1 L70/39 F/CORE HOLE| VA LOCKSCR Ø1.5 SELF-TAP L11 TAN| VA LOCKSCR Ø1.5 SELF-TAP L12 TAN