BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK

    MDR report key: 11404611 · Received March 3, 2021

    Report

    Report Number
    1219602-2021-00427
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 9, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MAI
    UDI-DI
    00885554031423
    PMA / PMN Number
    K123393
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. EVEN THOUGH ONE OF THE SUTURES UNLOADED, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE AND DID NOT REQUIRE ANY INTERVENTION. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN DURING A ROTATOR CUFF PROCEDURE WITH A HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK, ONE SUTURE UNLOADED AND THE OTHER SUTURE WAS STILL LOADED THROUGH THE IMPLANT AND WAS USED TO TIE THE CUFF DOWN. THE ISSUE WAS SOLVED WITH THE SAME DEVICE AND IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT HARM REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304279 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI SMITH & NEPHEW, INC. 2062981 00885554031423

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention