BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSTITCH PERFECTPASSER SUTURE CARTRID

    MDR report key: 8156353 · Received December 12, 2018

    Report

    Report Number
    3006524618-2018-00648
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 30, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GAT
    UDI-DI
    00817470005837
    PMA / PMN Number
    K123268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AS AN MDR FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED INCIDENT. VISUAL INSPECTION OF THE RETURNED OPUS SPEEDSCREW IMPLANT SHOWS A DEPLOYED DEVICE WITH AN IMPLANT WHICH IS NOT DETACHED OR DAMAGED. THE INSTRUMENT WAS RETURNED WITH THE FUNCTION SWITCH TOWARDS TO THE ¿BLACK¿ DOT. AT DISTAL END THE IMPLANT VISUALLY SHOW CONTAMINATION WITH DRIED PARTS OF TISSUE. NO MANUFACTURING ANOMALIES WERE IDENTIFIED. DURING FUNCTIONAL EVALUATION THE PARTIAL MOVED SUTURE LIMB CAN BE TENSIONED. BOTH SUTURE LIMBS WERE REELED INTO THE WHEELS. THE FUNCTION SWITCH COULD BE SET TOWARDS THE ¿DEPLOY¿ POSITION AND THE IMPLANT COULD BE DETACHED BY TURNING THE ACTIVATION KNOB 3-TIMES CLOCKWISE AS SPECIFIED. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT INCLUDES: (1) THERE MAY HAVE BEEN MISALIGNMENT OF THE DEVICE WHEN INSERTING (2) BEND AND APPLYING EXCESSIVE TORQUE COULD CAUSE REDUCED FUNCTIONALITY. THE INSTRUCTIONS FOR USE WAS REVIEWED AND DETERMINED TO HAVE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE AND NON-FUNCTIONALITY. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    PART NUMBER: OM-6500 SPEEDSCREW & LOT 2001966.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A LEFT SHOULDER CUFF REPAIR SURGERY, IT WAS USED: (A) 1 ANCHOR X OM-6500 SPEEDSCREW LOT 2001966, WITH (B) 1 X OM-8176EA SUTURE MAGNUM WIRE LOT 2008074; DESPITE A GOOD USE OF THE ANCHOR ON THE TENSION OF THE SUTURES, THE SUTURES BROKE WITHOUT LOGICAL EXPLANATION. THE PROCEDURE WAS FINISHED IN MINI-OPEN MODALITY AND USING A COMPETITOR DEVICE. THERE IS NOT REFERENCE TO WHETHER THERE WAS A DELAY IN THE SURGERY OR NOT. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997701 SMARTSTITCH PERFECTPASSER SUTURE CARTRID SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHROCARE CORP. 2008074 00817470005837

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PART NUMBER: OM-6500 SPEEDSCREW & LOT 2001966