BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8X30MM MILAGRO ADVANCE INTERFERENCE SCREW

    MDR report key: 7221821 · Received January 26, 2018

    Report

    Report Number
    1221934-2018-50109
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Report Date
    May 2, 2018
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K123362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION, HOWEVER PICTURES WERE PROVIDED. THE PICTURE OF THE LABEL WAS PROVIDED. THE PART NUMBER AND LOT NUMBER CAN BE CONFIRMED. THE ANCHOR INDEED IS STILL ATTACHED TO THE INSERTER SHAFT WITH VISIBLE SURGICAL DEBRIS LOCATED ON BOTH THE INSERTER AND THE ANCHOR, WHICH INDICATES THIS DEVICE WAS USED, CONFIRMING THIS COMPLAINT. UPON CLOSER OBSERVATION, THE THREADS SEEMED TO BE SEVERELY DISTRESSED THROUGHOUT THE ANCHOR BODY, INDICATING THE ANCHOR WAS FORCEFULLY INSERTED IN THE BONE HOLE. THE ANCHOR IS NOT DESIGNED TO BE UNSCREWED ONCE FULLY INSERTED IN THE BONE HOLE. ADDITIONALLY, THE DISTAL TIP OF THE SHAFT IS SHOWN TO BE PROTRUDING THROUGH THE ANCHOR TIP FURTHER CONFIRMING THE ANCHOR WAS EXCESSIVELY FORCED IN THE BONE HOLE TO THE POINT THE INSERTER PIERCED THROUGH THE ANCHOR. THEREFORE, CAUSING THE ANCHOR TO BE JAM STUCK ON THE INSERTER SHAFT. POSSIBLE ROOT CAUSE FOR THE OBSERVED FAILURE INCLUDES OFF AXIS INSERTION, LEVERING DURING INSERTION, USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE, OR SLIGHT SMALL BONE HOLE PREPARATION. THE ANCHOR OBSERVED IN THE PICTURE COULD¿VE FAILED DUE TO A SLIGHT SMALL BONE HOLE PREPARATION, WHICH COULD HAVE CAUSED THE FAILURE. THIS FAILURE COULD BE ATTRIBUTED TO USER TECHNIQUE. THE DHR REVIEW INDICATED THAT THIS BATCH OF DEVICES WERE PROCESSED WITHOUT INCIDENT, THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE RECORDS REVIEWED. FURTHER, A REVIEW OF THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4) - INCOMPLETE THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). UDI:(B)(4) INCOMPLETE. THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW DRIVER CANNOT BE DETACHED FROM THE SCREW (SEE ATTACHED PICTURES). NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW DRIVER CANNOT BE DETACHED FROM THE SCREW. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION FROM AFFILIATE ON 2/06/2018: THE PRODUCT INFORMATION FOR THE RATCHET WRENCH DRIVER THAT WAS USED WHEN THE FAILURE OCCURRED IS AS FOLLOWED: (PRODUCT CODE: 231832, LOT NUMBER: 3865766). THE RESULTING SURGICAL DELAY WAS 30 MINUTES. THE PROCEDURE WAS ABLE TO BE COMPLETED. THE INSTRUMENT WAS IN USE FOR 15 MINUTES. [MISTAKENLY INCORRECT SELECTION MADE FOR IMPACT PRODUCT UNDER "PRODUCT RETURN STATUS" (RBI - NOT REQUESTED). THE SCREW WAS DISCARDED; NO PRODUCT WAS RETURNED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65342 8X30MM MILAGRO ADVANCE INTERFERENCE SCREW ORTHOPAEDIC BONE SCREW, BIOABSORBABLE HWC DEPUY MITEK 3865766

    Patients

    Seq Age Sex Outcome Treatment
    1