BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III W/O HOOK

    MDR report key: 8059403 · Received November 12, 2018

    Report

    Report Number
    1221934-2018-55259
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    October 16, 2018
    Report Date
    October 23, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705020218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. 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 IS NOT BEING RETURNED, MULTIPLES ATTEMPTS FOR PRODUCT RETURN WERE MADE WITH NO RESPONSE, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. FURTHER, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DEVICE HISTORY RECORD (DHR) REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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. (B)(4)- INCOMPLETE THE LOT NUMBER IS NOT CURRENTLY AVAILABLE. CORRECTED DATA: DEVICE AVAILABLE FOR EVALUATION

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6). (B)(6)-INCOMPLETE. THE LOT NUMBER IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE SURGEON COULD NOT LOAD THE GUN (WITH PERMATAPE), AND COULD NOT CLOSE THE JAWS OF THE GUN. HE NOTICED THAT THIS WAS DUE TO THE TIP BEING BENT. HE HAD TO USE A SIMILAR ITEM FROM A LOAN KIT (EXPRESSEW GUN WITH A HOOK, REF 214124) WHICH HE DOES NOT LIKE. 2 MINUTES DELAY IN SURGERY, NO AE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899015 EXPRESSEW III W/O HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 10886705020218

    Patients

    Seq Age Sex Outcome Treatment
    1