BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027754-2018-00022

    MDR report key: 7737271 · Received July 31, 2018

    Report

    Report Number
    2027754-2018-00022
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 1, 2018
    PMA / PMN Number
    K141550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF WHY THE PHALANGE BONE BROKE AFTER IMPLANTATION OF THE INSTAFIX 10MM X 10 MM STAPLE COULD NOT BE DETERMINED. ACCORDING TO THE INFORMATION SUPPLIED BY THE SALES REP, THE PATIENT DID NOT HAVE GOOD BONE QUALITY. THIS IS A DIRECT CONTRAINDICATION FOR USE OF THE IMPLANT PER THE INSTAFIX IFU. THE REP ALSO NOTED THAT IT IS "NOT UNCOMMON" FOR THIS BONE TO BREAK DURING THE AKIN OSTEOTOMY SURGICAL PROCEDURE. ANOTHER POSSIBILITY IS THE OVER-COMPRESSION OF THE 10X10 STAPLE. THIS PARTICULAR ISSUE IS UNDER INVESTIGATION VIA AN INTERNAL CAPA. THE REVIEW OF DHR DID NOT IDENTIFY ANY NON-CONFORMANCES WITH RELEASE. A TWO-YEAR REVIEW IDENTIFIED THE CAPA WHICH WAS OPENED DUE TO THIS ISSUE. A TWO-YEAR REVIEW OF THE NCR DATABASE DID NOT SHOW ANY NCR'S RELATED TO THIS IMPLANT. A TWO-YEAR REVIEW SHOWED THIS TO BE THE SECOND COMPLAINT WHERE THIS STAPLE CONTRIBUTED TO FRACTURING A BONE POST-IMPLANTATION. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    ON 06/01/2018, OSTEOMED WAS NOTIFIED OF AN INCIDENT CONCERNING ONE OF OUR INSTAFIX STAPLE DEVICES. PER THE SALES REPRESENTATIVE, A STANDARD AKIN OSTEOTOMY WAS PERFOMRED ON THE GREAT TOE. AN 8X8 INSTAFIX (P/N 400-3701) WAS USED FOR FIXATION. AN X-RAY WAS THEN TAKEN TO CONFIRM ALIGNMENT. THE INTEROPERATIVE X-RAY SHOWED THE OSTEOTOMY WAS NOW DISPLACED AND THE STAPLE WAS COMPRESSED COMPLETELY, BOTH LEGS OF IMPLANT WERE TOUCHING. IT WAS EXPLANTED AND WE DRILLED NEW WHOLES FOR A 10X10 INSTAFIX STAPLE (400-3703). AN X-RAY WAS TAKEN AND THIS STAPLE ALSO OVER COMPRESSED. THE HINGE OF THE BONE ALSO NOW APPEARED TO HAVE BEEN BROKEN. THE STAPLE WAS THEN EXPLANTED AND TWO CROSSING K-WIRE WERE USED TO FIXATE THE OSTEOTOMY. THE WOUND WAS CLOSED. ON 07/31/2018, OSTEOMED RECEIVED ADDITIONAL INFORMATION THAT THE OVER-COMPRESSION CAUSED THE BONE TO BREAK. THE BONE WAS NOT BROKEN PRIOR TO PLACEMENT OF THE SECOND STAPLE. THE TWO CROSSING K-WIRES WERE PLACED TO FIXATE BOTH THE BUNION AND THE BROKEN HINGE ON THE BONE.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention