BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CHISEL FOR ADULT ANGD BLADE PLS 320

    MDR report key: 12036472 · Received June 21, 2021

    Report

    Report Number
    2939274-2021-03092
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Report Date
    June 15, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZO
    UDI-DI
    10886982192561
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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. H10 ADDITIONAL NARRATIVE: B5. 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. B5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, TWO DEPTH GAUGE TIPS WERE BENT AND BROKEN. EIGHT THREADED DRILL GUIDE, FOUR DRILL BIT, TWO END CAP, TWO CANNULATED CHISEL, TWO CHISEL GUIDE, AND LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE HAD WERE INVOLVED IN THREADS STRIPPING VA LOCKING HOLES. CHISEL AND GUIDE WERE BENT DURING PROCESS OF INSERTION. NO FRAGMENTS WERE GENERATED. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS 1 OF 6 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE:: WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.: COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION.: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, TWO DEPTH GAUGE TIP WAS BENT AND BROKE. EIGHT THREADED DRILL GUIDE, FOUR DRILL BIT, TWO END CAP, TWO CANNULATED CHISEL, TWO CHISEL GUIDE, AND LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE HAD AN UNKNOWN ALLEGATION. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWENTY-THREE (23) DEVICES. THIS REPORT IS FOR FOUR (4) OF THE 23 DEVICES. THIS REPORT IS FOR ONE (1) CANN CHISEL FOR ADULT ANGD BLADE PLS 320 THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927509 CANN CHISEL FOR ADULT ANGD BLADE PLS 320 CHISEL, SURGICAL, MANUAL FZO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 332.121 10886982192561

    Patients

    Seq Age Sex Outcome Treatment
    1