BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR

    MDR report key: 10077224 · Received May 20, 2020

    Report

    Report Number
    3006524618-2020-00278
    Event Type
    Injury
    Date Received
    May 20, 2020
    Date of Event
    April 9, 2020
    Report Date
    July 21, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    MBI
    UDI-DI
    00885556614204
    PMA / PMN Number
    K153669
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3,H6: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. THE MULTIFIX S ULTRA KNOTLESS ANCHOR IS FULLY DETACHED AND 2 PARTS OF IT WERE SENT WITH THE DEVICE. THE TIP OF THE ANCHOR IS DAMAGED. THE RETURNED DEVICE IS A SINGLE-USED DEVICE AND COULD NOT BE FUNCTIONAL TESTED. AN ATTEMPT WAS MADE TO TEST THE BASIC FUNCTIONS. THE DEPLOYMENT KNOB CAN BE ROTATED UNTIL STOP. THE END CAP AND THE ROD CAN BE CONTINUOUSLY ROTATED IN BOTH DIRECTIONS. THE SUTURE LOADER WAS SENT WITH THE DEVICE AND IS INTACT. NO SUTURES RETURNED WITH THE DEVICE. VISUAL INSPECTION OF THE INSTRUMENT SHOWS NO DAMAGES OR MANUFACTURING ABNORMALITIES. THE INSTRUCTION FOR USE WAS REVIEWED AND CONTAINS THE FOLLOWING: DO NOT BEND OR TWIST THE INSERTER HANDLE DURING AND AFTER INSERTION AS DAMAGE TO THE IMPLANT OR INCOMPLETE INSERTION MAY RESULT. DO NOT DEPLOY A BENT OR DAMAGED IMPLANT. CAUTION: IF THE POUND-IN TIP DOES NOT PENETRATE THE BONE ON THE FIRST STRIKE, CREATE A BONE HOLE ACCORDING TO STEP 3. USE A NEW ANCHOR IN THE BONE HOLE. ¿ CAUTION: USE CARE TO PROPERLY ALIGN THE IMPLANT AND INSERTER HANDLE WITH THE BONE HOLE DURING POUND-IN. AVOID EXCESSIVE PROBING. DO NOT BEND OR TWIST THE INSERTER HANDLE DURING AND AFTER INSERTION AS DAMAGE TO THE IMPLANT OR INCOMPLETE INSERTION MAY RESULT. DO NOT DEPLOY A BENT OR DAMAGED IMPLANT. A REVIEW OF MANUFACTURING RECORDS FOR THIS L/N 2032464 FOUND NO DEVIATIONS OR NON-CONFORMANCE'S DURING THE MANUFACTURING PROCESS. CLINICAL/MEDICAL EVALUATION: ALTHOUGH IT WAS REPORTED THE PROCEDURE COMPLETED WITHOUT A DELAY, THE INFORMATION PROVIDED IS INSUFFICIENT TO DETERMINE HOW THE PROCEDURE WAS COMPLETED. THE PRODUCT EVALUATION CONFIRMED THE BREAKAGE; HOWEVER, THE ROOT CAUSE OF THE BREAKAGE COULD NOT BE CONFIRMED. SINCE NO HARM HAS BEEN ALLEGED TO THE PATIENT, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ADDITIONAL MEDICAL INFORMATION BE PROVIDED, THIS COMPLAINT WILL BE RE-ASSESSED. THE COMPLAINT WAS VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. FACTORS UNRELATED TO THE DESIGN AND MANUFACTURE OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT ARE (1) EXCESSIVE FORCE (2) OVER TENSIONING THE SUTURES (3) NOT ADHERE TO THE CORRESPONDING IFU BY BENDING OR TWISTING THE INSERTER HANDLE DURING AND AFTER INSERTION. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, THE MULTIFIX ANCHOR CANNOT BE USED DUE TO DAMAGE TO THE FRONT SHAFT PART DURING THE ANCHOR INSERTION PROCESS. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED, BUT THERE WERE NO DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537708 MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORP. 2032464 00885556614204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R