BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE ANCHOR

    MDR report key: 4173985 · Received October 15, 2014

    Report

    Report Number
    0001825034-2014-08056
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN . DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY KEITH S. HECHTMAN, MD, JOHN E. ZVIJAC, MD, MATT E. WELLS, MD, AND ANGIE BOTTO-VAN BEMDEN PHD; AM J SPORTS MED 2011 39: 342 ORIGINALLY PUBLISHED ONLINE DECEMBER 15, 2010, DOI: 10.1177/0363546510385401. 510K NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT BIOMET PRODUCT WAS NOT BEING REFERENCED IN THE JOURNAL ARTICLE. THEREFORE, PLEASE DISREGARD THE REPORT ASSOCIATED WITH THIS MFR NUMBER AS THE EVENTS REFERENCED DID NOT INVOLVE BIOMET MANUFACTURED PRODUCT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "LONG-TERM RESULTS OF ULNAR COLLATERAL LIGAMENT RECONSTRUCTION IN THROWING ATHLETES BASED ON A HYBRID TECHNIQUE¿ WHICH FOLLOWED THIRTY-FOUR (34) PATIENTS WHO WERE BASEBALL PLAYERS. THE ARTICLE CONCLUDED THAT THE HYBRID FIXATION TECHNIQUE RESULTED IN A LOW COMPLICATION RATE AND ALLOWED FULL RECOVERY TO PRE-INJURY LEVELS OF PERFORMANCE IN A MAJORITY OF THE PATIENTS. THIS STUDY WAS CONDUCTED OVER A PERIOD OF EIGHT YEARS (1997 TO 2002) AND REPORTS THE RESULTS OBTAINED FROM THIS HYBRID TECHNIQUE IN A TOTAL OF THIRTY-FOUR (34) THROWING ATHLETES (29 WERE PITCHERS). PATIENTS HAD AN ULNAR COLLATERAL LIGAMENT RECONSTRUCTION PROCEDURE. TWO ANCHORS USED PER CASE IN A HYBRID ULNAR OSSEOUS TUNNEL AND SUTURE ANCHOR FIXATION ON THE HUMERUS. THE JOURNAL ARTICLE REPORTS, AFTER A MINIMUM FOLLOW-UP TIME OF 4.2 YEARS, 85% OF PATIENTS HAD THE ABILITY TO RETURN TO COMPETITION AT OR ABOVE THE PRE-INJURY LEVEL OF PARTICIPATION. FIVE PATIENTS (14%) DID NOT RETURN TO THEIR PRE-INJURY LEVEL OF PLAY AND ONE PATIENT PRESENTED WITH TEMPORARY ULNAR NERVE PARESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656013 UNKNOWN SUTURE ANCHOR FASTENER, FIXATION KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R