BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR ANTEGRADE STD LOCKING

    MDR report key: 12086834 · Received June 29, 2021

    Report

    Report Number
    2939274-2021-03294
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 7, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982067210
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6: PART 03.010.049, LOT 8890619: RELEASE TO WAREHOUSE DATE: MAY 06, 2014. MANUFACTURER: HAGENDORF. NO NON-CONFORMANCE REPOTS (NCR'S) WERE GENERATED DURING PRODUCTION. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED FEW NICKS AND SCRATCHES ON THE SURFACE OF THE AIMING ARM. A FUNCTIONAL ASSESSMENT WAS NOT PERFORMED WITH THE COMPLAINT DEVICE SINCE THE APPLICABLE MATING COMPONENT(S) WERE NOT RETURNED. NO DIMENSIONAL INSPECTION WAS PERFORMED AS THERE WAS NO DAMAGE. THE CURRENT AND MANUFACTURED TO DRAWINGS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THIS COMPLAINT IS NOT CONFIRMED AS NO DEFECT WAS OBSERVED THAT COULD IMPACT THE FUNCTIONALITY OF THE DEVICE; HOWEVER SCRATCHES AND NICKS WERE OBSERVED. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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

    PRODUCT COMPLAINT # (B)(4). 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. 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

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE DYNAMIC DRILLING OF THE HOLE, THE FLUTED DRILL BIT CONTACTED TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) AIMING ARM FOR ANTEGRADE STD LOCKING. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980012 AIMING ARM FOR ANTEGRADE STD LOCKING GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.049 8890619 10886982067210

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR 10 TI CANN RETRO/ANTEGRADE FEM NL/360-S| 4.2 3-FLTD DRILL BIT QC/330/100 CALIB| 10 TI CANN RETRO/ANTEGRADE FEM NL/360-S| 4.2 3-FLTD DRILL BIT QC/330/100 CALIB