BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE CORRECTION KEY

    MDR report key: 10945339 · Received December 4, 2020

    Report

    Report Number
    1526439-2020-02354
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 6, 2020
    Report Date
    November 9, 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
    KS
    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: H6- THE COMPLAINT CONDITION WAS CONFIRMED FOR THE VERSE CORRECTION KEY (P/N: 199721000, LOT #: 220200). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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: 199721000 LOT : 220200. WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 22.10.2018. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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 · 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. D11: CONCOMITANT PRODUCT ADDED TO COMPLAINT. INVESTIGATION SUMMARY BACKGROUND: 1. SCREW DAMAGE DUE TO CORRECTION KEY DAMAGE. 2. INNER GREY PART ISN'T LOCKED. (B)(6) 2020 UPDATED EVENT DESCRIPTION: THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. (B)(6) 2020 UPDATED EVENT DESCRIPTION: THE SCREW HAS INNER THREAD DAMAGED DUE TO MULTIPLE TRYING TO ENGAGE CORRECTION KEY WHILE THE CORRECTION KEY HAS THE INNER GREY PART ISN¿T LOCKED. INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE VERSE CORRECTION KEY (P/N: 199721000, LOT #: 220200) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE MOST DISTAL THREAD WAS OBSERVED TO BE DEFORMED. THERE WERE SCRATCHES AND DISCOLORATION WAS OBSERVED ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER DEFECTS WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: DURING FUNCTIONAL TEST, THE ROD LOCK COMPONENT WAS ABLE TO ASSEMBLE AND DISASSEMBLE FROM THE POLY LOCK WITHOUT ANY ISSUES BUT THE CORRECTION KEY WAS NOT ABLE TO ASSEMBLE ONTO THE 5.5 EXP VERSE SCREW 6.0 X 4.0 (P/N: 199721640, LOT #: 224314) BECAUSE OF THE DEFORMED DISTAL THREAD. THE 5.5 EXP VERSE SCREW 6.0 X 4.0 WAS BEING INVESTIGATED. THE COMPLAINT CAN BE REPLICATED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: THE OUTER DIAMETER OF THE SCREW HEAD WAS MEASURED TO BE WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. EXPEDIUM VERSE - DUAL LOCK ASSEMBLY: DWG-887010006, REV. E/D. EXPEDIUM VERSE - DUAL LOCK POLY LOCK: DWG-887010007, REV. B. COMPLAINT WAS CONFIRMED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE VERSE CORRECTION KEY (P/N: 199721000, LOT #: 220200). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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: DEVICE HISTORY LOT: DHR OF PRODUCT CODE: 199721000. LOT : 220200. WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 22.10.2018. QTY: 200. H11: H4 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 PRODUCT CODE KWP; KWQ; MNH; MNI; OSH. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, THE SCREW HAS INNER THREAD DAMAGED DUE TO MULTIPLE TRYING TO ENGAGE CORRECTION KEY WHILE THE CORRECTION KEY HAS THE INNER GREY PART ISN¿T LOCKED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) VERSE CORRECTION KEY. THIS REPORT IS 5 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411222 VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH 199721000 10705034466132

    Patients

    Seq Age Sex Outcome Treatment
    1 5.5 EXP VERSE SCREW 6.0 X 40.| 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.| VERSE CORRECTION KEY.| VERSE CORRECTION KEY.| VERSE CORRECTION KEY.| VERSE CORRECTION KEY.| VERSE CORRECTION KEY.| VERSE CORRECTION KEY.| VERSE CORRECTION KEY.| 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| VERSE CORRECTION KEY| VERSE CORRECTION KEY| VERSE CORRECTION KEY