BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR/WASH DEPTH GAUGE *EA

    MDR report key: 7655215 · Received July 2, 2018

    Report

    Report Number
    1221934-2018-52778
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705005390
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED, AND FORWARDED TO NEW PRODUCT DEVELOPMENT (NPD) FOR EVALUATION. IT WAS INDICATED BY THE NPD QUALITY MANAGER THAT THE PRODUCT WAS NOT NON-CONFORMING PER THE DRAWING AS THERE IS A 4% TOLERANCE ASSOCIATED WITH THE MEASUREMENTS. THIS ATTRIBUTE HAS BEEN INCLUDED AS RISK MANAGEMENT BY DESIGN SUCH THAT THE RISK OF USER ERROR SELECTING A SCREW THAT IS TOO SMALL FOR THE BONE HOLE IS REDUCED. THEREFORE, THE USER MISINTERPRETED THE DEVICE ATTRIBUTES TO BE A FAULT. NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DEVICE HISTORY RECORD (DHR) REVIEW. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.¿ (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE DURING AN EPFL RECONSTRUCTION PROCEDURE THE CUSTOMER'S DEPTH GAUGE SCREW & WASHER SYSTEM 20M-80MM IS READING INACCURATE BY 6MM. THE SALES REP STATED THAT THE SURGEON WAS REALLY UPSET ABOUT THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE FROM A SYNTHES TRAY WITH NO HARM TO THE PATIENT BUT THERE WAS A 15 MINUTE DELAY TO GRAB THE OTHER TRAY. THE SALES REP STATED THAT THERE WAS NO LOT NUMBER ON THE DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497563 SCR/WASH DEPTH GAUGE *EA SURGICAL DEPTH GAUGE, REUSABLE LXH DEPUY MITEK LLC US UNK 10886705005390

    Patients

    Seq Age Sex Outcome Treatment
    1