BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM MICROMAX ANCHOR LONG SHAFT WITH MAXBRAID SUTURE

    MDR report key: 1571884 · Received January 7, 2010

    Report

    Report Number
    1825034-2010-00005
    Event Type
    Injury
    Date Received
    January 7, 2010
    Date of Event
    July 10, 2009
    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

    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. DATE OF EVENT IS UNKNOWNAS PART AND LOT NUMBER HAS NOT BEEN PROVIDED, MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN.IMPLANT AND EXPLANT DATES ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF EVENT - WAS UPDATED TO INCLUDE THE DATES OF SURGERIES. LOT NUMBER OTHER - TWO DIFFERENT LOT NUMBERS (423950 & 004260) FOR PART 905453 WERE IMPLANTED ON (B) (6) 2008, HOWEVER, IT COULD NOT BE DETERMINED WHICH ONE HAD THE ISSUE WITH THE ANCHOR DETACHING. EXPIRATION DATE - LOT 423950 EXPIRES 11/30/2012 AND LOT 004260 EXPIRES 01/31/2013. DEVICE MANUFACTURE DATE - LOT 423950 WAS MANUFACTURED 12/1/2007 AND LOT 004260 WAS MANUFACTURED 2/4/2008. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS FOR BOTH LOTS SHOW THAT BOTH LOTS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    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. THE PATIENT UNDERWENT REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL PROCEDURE UTILIZING A MICROMAX SUTURE ANCHOR ON (B) (6) 2008. SUBSEQUENTLY, APPROXIMATELY SIX MONTHS POST-OP, THE SURGEON RE-SCOPED THE PATIENT AND FOUND THAT THE ANCHOR HAD BECOME DETACHED FROM THE SUTURE PREMATURELY. A REVISION PROCEDURE WAS PERFORMED ON (B) (6) 2009.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R