BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSE X25 INSERTER/TIGHTENER

    MDR report key: 9122670 · Received September 26, 2019

    Report

    Report Number
    1526439-2019-52158
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    September 1, 2019
    Report Date
    September 1, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWR
    UDI-DI
    10705034467634
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UDI: (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. VISUAL EXAMINATION AT THE MICROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. THE SECOND HALF OF THE DRIVER¿S TIP WAS NOT RETURNED. THE FRACTURE ANALYSIS REPORT REVEALS PLASTIC DEFORMATION AT THE HEX LOBES AND TORSIONAL SHEAR MARKINGS FOLLOWING A CIRCULAR PATTERN. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THE DRIVER¿S DISTAL TIP BECOMING FRACTURED CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT SUGGESTS THAT THE FRACTURED TIP UNDERWENT A QUASI-STATIC OVERLOAD TORSIONAL SHEAR FAILURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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. 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 · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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

    DURING FINAL TIGHTENING, THE SURGEON MISTAKENLY TRIED TO FINAL TIGHTEN THE UNITIZED SET SCREW WITH THE WRONG HANDLE. THE EXCESSIVE FORCE ON THE VERSE INSERTER / TIGHTENER 299704230 DRIVER CAUSED THE TIP TO SHEAR OFF AND WAS COLD WELDED IN THE UNITIZED SET SCREW. ATTEMPTS WERE MADE TO REMOVE THE BROKEN TIP OF THE VERSE INSERTER /TIGHTENER, BUT WERE UNSUCCESSFUL. THE BROKEN TIP OF THE DRIVER REMAINS EMBEDDED IN THE UNITIZED SET SCREW IMPLANTED IN THE PATIENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN FRAGMENT, BUT IT REMAINS IMPLANTED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES - YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? FRAGMENT OF BROKEN DRIVER REMAINS IMPLANTED, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IF YES, DESCRIBE - FRAGMENT OF BROKEN DRIVER REMAINS IMPLANTED, IS THE PATIENT PART OF A CLINICAL STUDY - UNKNOWN. CONCOMITANT MEDICAL PRODUCT: UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919304 VERSE X25 INSERTER/TIGHTENER DRIVER, PROSTHESIS HWR MEDOS INTERNATIONAL SàRL CH 299704230 GM5037403 10705034467634

    Patients

    Seq Age Sex Outcome Treatment
    1 Other