BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO GRASPER PEN 35 UP *EA

    MDR report key: 14567106 · Received June 1, 2022

    Report

    Report Number
    1221934-2022-01547
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    NBH
    UDI-DI
    10886705003846
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UDI: (B)(4).THE LOT NUMBER WAS UNKNOWN. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE EXPIRATION DATE, MANUFACTURING SITE NAME AND DEVICE MANUFACTURE DATE WERE UNKNOWN. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H4: THE DEVICE MANUFACTURE DATE WAS REPORTED AS UNKNOWN ON THE INITIAL REPORT; AND HAS BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION AND FUNCTIONAL TEST OF DEVICE RECEIVED. UPON VISUAL INSPECTION WAS FOUND WEAR USE. IT COULD BE OBSERVED PEELING PAINT IN THE HANDLE OF THE DEVICE. THE MECHANISM TO OPEN AND CLOSE THE TWEEZER¿S TIP IS NOT WORKING, WHEN TRYING TO OPERATE THE DEVICE THE MECHANISM IS LOOSE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER:20C03, AND NO NONCONFORMANCES WERE IDENTIFIED. BASED ON THE VISUAL INSPECTION RESULTS, THIS COMPLAINT CANNOT BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE CONDITION OF THE DEVICE COULD BE RELATED TO HEAVILY USE; MOREOVER, DROP OF THE UNIT, MISHANDLING OR PROCEDURAL VARIABLES THAT COULD CAUSE THE LOOSE CONDITION OF THE DEVICE. SINCE THIS IS A REUSABLE DEVICE, THIS CONDITION HAS POSSIBLY OCCURRED AFTER USING IT FOR MANY PROCEDURES. HOWEVER, IT CANNOT BE CONCLUSIVELY AFFIRMED. AS PER IFU-, END OF USEFUL INSTRUMENT LIFE IS GENERALLY DETERMINED BY WEAR OR DAMAGE FROM HANDLING OR SURGICAL USE. INSPECT INSTRUMENTS BETWEEN USES TO VERIFY PROPER FUNCTIONING. VISUALLY INSPECT THE INSTRUMENT AND CHECK FOR DAMAGE AND WEAR, CUTTING EDGES SHOULD BE FREE OF NICKS AND HAVE A CONTINUOUS EDGE, JAWS AND TEETH SHOULD ALIGN PROPERLY, MOVEABLE PARTS SHOULD HAVE SMOOTH MOVEMENT WITHOUT EXCESSIVE PLAY, LOCKING MECHANISMS SHOULD FASTEN SECURELY AND CLOSE EASILY, LONG, THIN INSTRUMENTS SHOULD BE FREE OF BENDING AND DISTORTION IN ACCORDANCE WITH THE MANUFACTURER¿S INSTRUCTIONS. AT THIS POINT IN TIME, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP IN FRANCE THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ARTHRO GRASPER PEN 35 UP DEVICE BROKE BEFORE USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460989 ARTHRO GRASPER PEN 35 UP *EA SUTURE/NEEDLE PASSER, REUSABLE NBH DEPUY MITEK LLC US 214601 20C03 10886705003846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown