BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE CORRECTION KEY

    MDR report key: 10302911 · Received July 21, 2020

    Report

    Report Number
    1526439-2020-01359
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    May 26, 2020
    Report Date
    July 17, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034466132
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. H10 ADDITIONAL NARRATIVE: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED: INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE VERSE CORRECTION KEY (P/N: 199721000, LOT NUMBER: 243958) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE EXTERNAL THREADS WERE BROKEN OFF. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE EXTERNAL THREADS ARE BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: DEVICE HISTORY LOT. THE DHR OF PRODUCT CODE 199721000, LOT 243958, WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON MAY 28, 2019. QTY. (B)(4). THE DHR WAS ELECTRONICALLY REVIEWED. 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 NARRATIVE: ADDITIONAL PRODUCT CODE (B)(4). (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON AN UNKNOWN DATE THAT DURING A SURGERY ON (B)(6) 2020, WHEN THE SURGEON INSERTING THE CORRECTION KEY AND A UNITIZED SET SCREW IN THE EXTENDED TAP OF AN EXP VERSE CFX SCREW, BOTH INNIES ARE BROKE-THE RING/CHIP BROKE OFF. THE SURGEON THEN UNABLE TO USE CORRECTION KEY AND THE UNITIZE THE SET SCREW AND HAD TO CHANGE THE SCREW AND INNIES. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN KEY INSERTER/TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) VERSE CORRECTION KEY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769162 VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 199721000 243958 10705034466132

    Patients

    Seq Age Sex Outcome Treatment
    1 5.5 EXP VERSE FEN SCR 7.0X50.| 5.5 EXP VERSE UNITIZED SET SCR.| UNKNOWN SCREWDRIVERS.| 5.5 EXP VERSE FEN SCR 7.0X50| 5.5 EXP VERSE UNITIZED SET SCR| UNKNOWN SCREWDRIVERS