BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPEL TUNNEL SYNDROME (CTS) RELIEF KIT

    MDR report key: 11575837 · Received March 26, 2021

    Report

    Report Number
    1017294-2021-00163
    Event Type
    Injury
    Date Received
    March 26, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 11, 2021
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INVESTIGATION OF THE CUSTOMER'S COMPLAINT OF DETACHMENT OF BLUE PLASTIC FRAGMENTS IN THE SURGICAL WOUND DURING THE PASSAGE OF THE OPTIC THROUGH THE CAMERA HOLDER WAS NOT CONFIRMED. A VISUAL EXAMINATION OF RETURNED USED DEVICES ITEM 9971, QTY OF TWO (2), COULD NOT CONFIRM THE REPORTED PROBLEM AS THERE WAS NO DAMAGE TO THE PRODUCT. EXAMINATION WAS PERFORMED PER PRINT 9971. RESULTS OF THE DHR (DEVICE HISTORY RECORD) PROVIDED BY THE MANUFACTURER FOUND NO EVIDENCE TO INDICATE THAT THERE WERE ANY DEVIATIONS IN THE MANUFACTURING PROCESS. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 3 COMPLAINTS, REGARDING 5 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 11,958 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.0004. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH DETAILED INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. ALSO PER THE IFU THE USER IS ADVISED TO CAREFULLY REVIEW THE SURGICAL TECHNIQUE BROCHURE AND VIDEO BEFORE PERFORMING THIS PROCEDURE THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED AN ISSUE WITH THE INVOLVING A CTS RELIEF KIT, ITEM # 9971, LOT CN042834 (QTY 2). INFORMATION RECEIVED INDICATES (B)(6) CENTER REPORTED THAT THE CTS RELIEF KIT WAS BEING USED ON (B)(6) 2021 DURING A ENDOSCOPIC CARPEL TUNNEL SYNDROME TREATMENT. THE SURGEON REPORTED WHEN HE SLID THE LENS (BELIEVED TO BE AN ARTHEX SCOPE LENS) DOWN THE SCOPE GUIDE, A PIECE OF PLASTIC BROKE OFF OF THE GUIDE AND WENT INTO THE PATIENT'S WRIST. THEY OPENED A 2ND 9971 KIT AND USED A SCOPE LENS FROM SMITH AND NEPHEW AND THEY SAID THE SAME THING HAPPENED. THE SURGEON HAD TO CONVERT FROM ENDOSCOPIC TO OPEN CASE TO REMOVE THE PLASTIC AND COMPLETE THE RELEASE. ADDITIONALLY, IT IS NOTED THE PATIENT WAS (B)(6) AND HAD A DEGREE OF ARTHRITIS, WHICH THE SURGEON SAID COULD HAVE MADE THE CASE MORE CHALLENGING. HE MADE A LARGER INCISION TO IRRIGATE THE PLASTIC DEBRIS AND COMPLETED THE RELEASE OPEN. THE PATIENT HAS TO WEAR A WRIST BRACE UNTIL THE FOLLOW UP APPOINTMENT. ADDITIONAL INFORMATION OBTAINED NOTES THE OPTIC /LENS (SCOPE) WAS NOT BEING USED WITH A SLEEVE AS, PER THE FACILITY, THE PROCEDURE ITSELF IS NOT DESIGNED TO BE USED WITH A SLEEVE. THE DILATORS HAD ALREADY BEEN USED. THE "SHAVINGS" FROM THE INSIDE OF THE GUIDE WERE NOT NOTICED IN THE PATIENT'S WRIST UNTIL THE CAMERA WAS USED. AS SOON AS THE CAMERA WAS USED TO LOOK INSIDE, THE BLUE SHAVINGS WERE VISIBLE IN THE WRIST PRIOR TO MAKING THE INCISION FOR THE RELEASE. THE SURGEON AND THE SCRUB NURSE STATED THE SHAVINGS WERE FROM THE INSIDE OF THE GUIDE. NO OTHER INFORMATION WAS MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE TO FACILITATE REMOVING THE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473889 CARPEL TUNNEL SYNDROME (CTS) RELIEF KIT INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM DESIGN STANDARDS CORP CN042834

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other ARTHREX SCOPE LENS| SMITH & NEWPHEW SCOPE LENS