BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM ROD

    MDR report key: 10033071 · Received May 7, 2020

    Report

    Report Number
    8030965-2020-03351
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 23, 2020
    Report Date
    April 23, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKG
    UDI-DI
    07611819468573
    PMA / PMN Number
    K142838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 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.

    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: PART: 04.615.226S SYNTHES LOT: H835482, SUPPLIER LOT: N/A, RELEASE TO WAREHOUSE DATE: FEBRUARY 14, 2019, EXPIRATION DATE: N/A, MANUFACTURED BY SYNTHES BRANDYWINE. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. PART : 04.615.226S, SYNTHES LOT: H852599, MANUFACTURING SITE: SYNTHES MONUMENT, RELEASE TO WAREHOUSE DATE: MARCH 20, 2019, EXPIRATION DATE: MARCH 20, 2029. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE CANCELLOUS SCR SYNAPSE Ø4.5 L26 F/R Ø4 TA WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE INTERNAL THREADS OF THE CANCELLOUS SCREW HEAD WERE STRIPPED. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWING WAS REVIEWED. -4.5MM TI TOPLOADING CANC SCREW NEUTRAL 8MM-50MM INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE CANCELLOUS SCR SYNAPSE Ø4.5 L26 F/R Ø4 TA. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 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 MNH MNI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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 AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT A POSTERIOR SPINAL FUSION (PSF) IN C7 TREATING VERTEBRAL BODY FRACTURE ON (B)(6) 2020. THE NURSE WAS UNABLE TO MOUNT THE SCREW STRAIGHT ON A SCREWDRIVER. SHE TRIED WITH AVAILABLE SCREWDRIVERS TO CONNECT WITH THE SCREW SEVERAL TIMES, BUT THE SCREW WENT IN THE SKEW DIRECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACING SCREW LESS THAN 30-MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS: (PART# UNKNOWN; LOT# H835482; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495828 4.5MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM ROD ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG OBERDORF SYNTHES PRODUKTIONS GMBH H852599 07611819468573

    Patients

    Seq Age Sex Outcome Treatment
    1 CANCELLOUSSCR SYNAPSE Ø4.5 L26 F/R Ø4 TA| UNK - SCREWDRIVERS| CANCELLOUSSCR SYNAPSE Ø4.5 L26 F/R Ø4 TA| UNK - SCREWDRIVERS