BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM JIG FOR CONSTRAINED SHOULDER

    MDR report key: 2877012 · Received December 18, 2012

    Report

    Report Number
    0001825034-2012-02615
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. CUSTOM JIG IS A REUSABLE INSTRUMENT THAT IS SHIPPED FROM BIOMET PMI TO EACH CASE AS IT IS NEEDED. THIS INSTRUMENT HAS BEEN USED SUCCESSFULLY NUMEROUS TIMES.THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02615-2 /2013- 00089-1).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION INCLUDING PART NUMBER, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-002615-1 & 2013-00089).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE, IT WAS NOTED THE CUSTOM JIG DID NOT MATCH THE PICTURE PROVIDED AND THE SCREW DRIVER REQUESTED WAS NOT THE CORRECT SIZE TO TIGHTEN THE SMALL SCREWS. THE JIG NEEDED TO BE MANUALLY ALIGNED RESULTING IN A DELAY OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM JIG FOR CONSTRAINED SHOULDER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R