BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREWS

    MDR report key: 18622136 · Received February 1, 2024

    Report

    Report Number
    1526439-2024-00792
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 1, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H1: THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THE ACTUAL PRODUCT CODE WAS NOT AVAILABLE FOR THE INITIAL MW REPORT AND THEREFORE WAS SUBMITTED AS AN UNKNOWN PRODUCT CODE WITH THE ASSUMPTION THAT DEPUYSYTHES WAS THE LEGAL MANUFACTURER.  UPON RECEIPT OF THE PRODUCT CODE AND DURING FURTHER REVIEW OF THIS EVENT, IT WAS DETERMINED THAT DEPUYSYTHES  IS NOT THE LEGAL MANUFACTURER OF THIS DEVICE. THE LEGAL MANUFACTURER OF THE DEVICE ASSOCIATED TO THIS REPORT IS RESOLVE SURGICAL TECHNOLOGIES (PIONEER). AS RESOLVE SURGICAL TECHNOLOGIES (PIONEER) IS THE LEGAL MANUFACTURER, RESOLVE SURGICAL TECHNOLOGIES (PIONEER) HAS REPORTING RESPONSIBILITY FOR THIS MEDICAL DEVICE. RESOLVE SURGICAL TECHNOLOGIES (PIONEER) HAS BEEN NOTIFIED OF THIS EVENT. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. D1, D2A, D2B, D3, D4, G4: 510K: THIS REPORT IS FOR AN UNK: SCREWS, UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT: PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 0

    IT WAS FURTHER REPORTED. IT WAS NOTED THE SURGICAL TECHNIQUE WAS FOLLOWED. ANOTHER DEVICE WAS NOT NEEDED/USED FOR THE COMPLETION OF THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT A NEGATIVE OUTCOME TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON WAS SUCURING A 60MM CODA CERVICAL PLATE, UPON PLACING A 18MM SELF DRILLING VARIABLE ANGLE SCREW INTO THE C4 VERTEBRAL BODY. THE SCREW PRESSED BEYOND THE INTERFACE OF THE PLATE AND INTO THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1): UNKNOWN SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419827 UNKNOWN SCREWS SCREW, FIXATION, BONE HWC MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male