BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM MICROMAX ANCHOR FLEXIBLE LONG SHAFT WITH MAXBRAID SUTURE

    MDR report key: 1571891 · Received January 7, 2010

    Report

    Report Number
    1825034-2010-00006
    Event Type
    Injury
    Date Received
    January 7, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    K040475
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF EVENT - WAS UPDATED TO INCLUDE THE DATES OF THE ORIGINAL SURGERY.LOT NUMBER OTHER - THREE DIFFERENT LOT NUMBERS (028000, 027970 & 745790) FOR PART 905456 WERE IMPLANTED ON (B) (6) 2009, HOWEVER, IT COULD NOT BE DETERMINED WHICH ONE HAD THE ISSUE WITH THE ANCHOR DETACHING. EXPIRATION DATE - LOT 028000 EXPIRES 1/31/2014, LOT 027970 EXPIRES 01/31/2014 AND LOT 745790 EXPIRES 09/30/2013.DEVICE MANUFACTURE DATE - LOT 028000 WAS MANUFACTURED 1/22/2009, LOT 027970 WAS MANUFACTURED 2/9/2009 AND LOT 745790 WAS MANUFACTURED 9/25/2008.CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS FOR ALL LOTS SHOW THAT THEY RELEASED WITH NO RECORDED ANOMALY.

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. NUMEROUS ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON. TO DATE, PRODUCT IDENTIFICATION HAS NOT BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A FOLLOW UP REPORT WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL PROCEDURE UTILIZING A MICROMAX SUTURE ANCHOR ON (B) (6) 2009. SUBSEQUENTLY, APPROXIMATELY SIX MONTHS POST-OP, THE SURGEON RE-SCOPED THE PATIENT AND FOUND THAT THE ANCHOR HAD BECOME DETACHED FROM THE SUTURE PREMATURELY. PATIENT IS EXPECTED TO UNDERGO REVISION PROCEDURE, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE REGARDING REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL PROCEDURE UTILIZING A MICROMAX SUTURE ANCHOR. SUBSEQUENTLY, APPROXIMATELY SIX MONTHS POST-OP, THE SURGEON RE-SCOPED THE PATIENT AND FOUND THAT THE ANCHOR HAD BECOME DETACHED FROM THE SUTURE PREMATURELY. PATIENT IS EXPECTED TO UNDERGO REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.9MM MICROMAX ANCHOR FLEXIBLE LONG SHAFT WITH MAXBRAID SUTURE FIXATION, SCREW HWC BIOMET SPORTS MEDICINE N/A OTHER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention