BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 EXP VERSE DI SET SCREW

    MDR report key: 11301649 · Received February 9, 2021

    Report

    Report Number
    1526439-2021-00262
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 20, 2021
    Report Date
    January 20, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034466125
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE. D4: UDI. D9: PART RETURNED. D10: ADDITIONAL CONCOMITANT DEVICE REPORTED. H3, H4, H6: DEVICE HISTORY LOT. THE DHR OF PRODUCT CODE: 199721000S. LOT : 142616. WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 27.06.2017. QTY: (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THIS WAS A PLIF TREATING SPONDYLOLISTHESIS AT L5/S ON (B)(6) 2021. AFTER A ROD WAS DEPLOYED, THE SURGEON WAS NOT ABLE TO TIGHTEN THE COLLECTION KEY. ALSO, METAL POWDERS CAME OUT. THE SURGEON RETRIED WITH TWO MORE REPLACING COLLECTION KEYS, WHICH BOTH FAILED. SO HE REPLACED THE SCREW THIS TIME AND TIGHTENED ALL THE DEVICES. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THE PRODUCT WAS RETURNED TO THE US CQ FOR EVALUATION. US CQ CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SET SCREW IMPLANT EXTERNAL THREADS WERE STRIPPED AND FEW THREADS WERE PEELED OFF. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE STRIPPED AND PEELED CONDITION OF THE EXTERNAL THREADS WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED/OVERT FORCES. IT SHOULD BE NOTED THAT AS PART OF DEPUY SPINE¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED STRIPPED AND PEELED CONDITION WOULD CONTRIBUTE TO THE ALLEGED DEVICE ASSEMBLY ISSUE. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THE EXTERNAL THREADS OF THE SET SCREW IMPLANT WERE STRIPPED AND PEELED DUE TO UNINTENDED/OVERT FORCES. 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 DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWING REFLECTING THE CURRENT AND MANUFACTURED REVISION WAS REVIEWED: DWG-887010006 REV. E. 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

    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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) TREATING SPONDYLOLISTHESIS AT L5/S, AFTER A ROD WAS DEPLOYED, THE COLLECTION KEY WAS NOT ABLE TO BE TIGHTENED. ALSO, METAL POWDERS CAME OUT. TWO (2) ADDITIONAL COLLECTION KEYS WERE TRIED BUT BOTH FAILED. THE SCREW WAS REPLACED AND ALL OF THE DEVICES WERE TIGHTENED. THE PROCEDURE WAS DELAYED LESS THAN THIRTY (30) MINUTES. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE DI SET SCREW. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201276 5.5 EXP VERSE DI SET SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 199721000S 142616 10705034466125

    Patients

    Seq Age Sex Outcome Treatment
    1 5.5 EXP VERSE CAN SCR 6.0X30| 5.5 EXP VERSE DI SET SCR| 5.5 EXP VERSE DI SET SCR| 5.5 EXP VERSE DI SET SCR| UNKNOWN SCREWDRIVERS