BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE PASSER NEEDLE

    MDR report key: 5943847 · Received September 12, 2016

    Report

    Report Number
    3004086872-2016-00002
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 8, 2016
    Report Date
    September 12, 2016
    Manufacturer
    COORSTEK MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE PRODUCT RECEIVED: RETURN OF PRODUCT WAS REQUESTED. AN E-MAIL WAS RECEIVED 8-30-2016 STATING THE PRODUCT WOULD NOT BE RETURNING. DEVICE IDENTIFICATION: (B)(4). VISUAL INSPECTION: WHERE PRODUCT WAS NOT RETURNED A VISUAL INSPECTION WAS NOT PERFORMED. FUNCTIONAL INSPECTION: WHERE PRODUCT WAS NOT RETURNED A FUNCTIONAL INSPECTION WAS NOT PERFORMED. ADDITIONAL INVESTIGATION NOTES: DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THE THREE MANUFACTURE LOTS REPORTED IN THE COMPLAINT INVESTIGATION. FURTHER REVIEW SHOWED NEEDLES, (B)(4), MANUFACTURED UNDER LOT 992658 MET THE PRINT REQUIREMENT OF 95% CONFIDENCE THAT 99% OF THE LOT WOULD MEET A MINIMUM OF 24 CYCLES WITH 95% CONFIDENCE THAT 99.9% WOULD MEET THE 24 CYCLE MINIMUM. ADDITIONAL INFORMATION WAS RECEIVED VIA E-MAIL THAT STATED, "IT BROKE THE TIP OF THE NEEDLE INTO THE JOINT. IT WAS REMOVED BY MEANS OF WASHING. THE DIFFICULTY IN PASSING THE THREAD TOOK PLACE WITH BOTH FORCEPS". WITH LIMITED INFORMATION THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE DESCRIPTION OF THE NON-CONFORMANCE INDICATES THERE WAS A PROBLEM PASSING THE SUTURE THROUGH WITH BOTH INSTRUMENTS. IT IS PROBABLE THAT IT WAS DUE TO THE PATIENT'S ANATOMY AND NOT DUE TO AN ISSUE WITH THE SUTURE PASSER OR NEEDLE. SERVICE HISTORY REVIEW: THERE HAS BEEN NO SERVICE ON THIS PRODUCT. ALLEGED PROBLEM CONFIRMED: WHERE THE PRODUCT WAS NOT RETURNED THE ALLEGED PROBLEM COULD NOT BE CONFIRMED. ACTUAL FAILURE MODE(S): NEEDLE BROKE. ROOT CAUSE(S): WHERE THE PRODUCT WAS NOT RETURNED A ROOT CAUSE COULD NOT BE DETERMINED. MANUFACTURER ERROR: DEVICE HISTORY RECORD REVIEW SHOWED NO MANUFACTURE ERROR WITH THE MANUFACTURE LOTS LISTED IN THE COMPLAINT INVESTIGATION. PRODUCT WAS UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    ALLEGED PROBLEM(S): "IT BROKE THE NEEDLE TIP". WE ARE TRYING TO FIND OUT IF ALL THREE DEVICES BROKE. DURING SURGERY PRODUCT (COMPLAINT SAMPLE) IS IN THE FIELD, TRYING TO RETRIEVE IT. NO ASSOCIATED PROCEDURE. NO DELAYS. NO ADVERSE CONSEQUENCES. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593787 SUTURE PASSER NEEDLE SUTURE PASSER NEEDLE, BOX OF 5 GAB COORSTEK MEDICAL 3910-900-091 992658

    Patients

    Seq Age Sex Outcome Treatment
    1