BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 EXP VERSE SCREW 6.0 X 40

    MDR report key: 10540302 · Received September 16, 2020

    Report

    Report Number
    1526439-2020-01705
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 19, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNI
    UDI-DI
    10705034442280
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED: INVESTIGATION FLOW: FUNCTIONAL/DEVICE INTERACTION. VISUAL INSPECTION: THE 5.5 EXP VERSE SCREW 6.0 X 40 (P/N: 199721640, LOT NUMBER: 256371) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE HEAD OF THE SCREW WAS LOCKED IN THE MONOAXIAL POSITION. PER THE SYSTEM GUIDE DSUS/SPN/0115/0747(1), THE POLYAXIAL SCREW CONVERTS TO A MONOAXIAL SCREW UPON TIGHTENING OF THE SET SCREW. THE SYSTEM GUIDE INDICATES THAT EXCEEDING THE SYSTEM TORQUE MAY RESULT IN FAILURE OF THE IMPLANT. UPON LOOSENING OF THE SET SCREW, THE SCREW HEAD SHOULD BECOME MOBILE AGAIN. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE. THE HEAD OF THE SCREW WAS UNABLE TO BE MOVED FROM THE RECEIVED POSITION. THE COMPLAINT WAS ABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THE COMPLAINT WAS CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE SCREW HEAD IS UNABLE TO MOVE. A POSSIBLE ROOT CAUSE IS OVER-TORQUING OF THE SET SCREWS, HOWEVER NO DEFINITIVE ROOT CAUSE COULD BE IDENTIFIED. 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. DEVICE HISTORY LOT: THE DHR OF PRODUCT CODE 199721640, LOT 256371, WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON OCTOBER 3, 2019. QTY. 400. 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 DEVICE PRODUCT CODES: NKB, KWQ, KWP, MNH, OSH. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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 ON (B)(6) 2020, DURING A SPINE REVISION SURGERY, THE HEAD OF THE VERSE SCREWS DID NOT BECOME POLIAXIAL AND THE SCREWDRIVER COULD NOT BE INSERTED TO TAKE OUT THE SCREWS. THE LOCKING SCREWS AND RODS WERE REMOVED. ANOTHER INSTRUMENT WAS USED TO REMOVE TO REMOVE THE SCREWS. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICE REPORTED: RODS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREW/ SET SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 269766, QUANTITY 3), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 218140, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 45 (PART NUMBER 199721645, LOT 240964, QUANTITY 1), 5.5 EXP VERSE SCREW 6.0 X 40 (PART NUMBER 199721640, LOT 226103, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 40MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008502 5.5 EXP VERSE SCREW 6.0 X 40 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD MNI MEDOS INTERNATIONAL SàRL CH 199721640 256371 10705034442280

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 5.5 EXP VERSE SCREW 6.0 X 40.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| UNKNOWN LOCKING/SET SCREWS.| UNKNOWN RODS.| UNKNOWN SCREWDRIVERS.| 5.5 EXP VERSE SCREW 6.0 X 40.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| 5.5 EXP VERSE SCREW 6.0 X 45.| UNKNOWN LOCKING/SET SCREWS.| UNKNOWN RODS.| UNKNOWN SCREWDRIVERS.