BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE INSTRUMENT SPRING DRILL PIN

    MDR report key: 2010962 · Received March 8, 2011

    Report

    Report Number
    1825034-2011-00152
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6), 2011 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND USER FACILITY REPORT NUMBER REFERENCED IN THIS MEDWATCH ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2011. POST-OPERATIVE RADIOGRAPHS REVEALED THAT THE THREADED PORTION OF THE SPRING DRILL PIN HAD FRACTURED AND HAD BEEN RETAINED BY THE PATIENT. TO DATE, NO REVISION PROCEDURE HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6), 2011. POST-OPERATIVE RADIOGRAPHS REVEALED THAT THE THREADED PORTION OF THE SPRING DRILL PIN HAD FRACTURED AND HAD BEEN RETAINED BY THE PATIENT. TO DATE, NO REVISION PROCEDURE HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6), 2011. POST-OPERATIVE RADIOGRAPHS REVEALED THAT THE THREADED PORTION OF THE SPRING DRILL PIN HAD FRACTURED AND HAD BEEN RETAINED BY THE PATIENT. TO DATE, NO REVISION PROCEDURE HAS BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE INSTRUMENT SPRING DRILL PIN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S