BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET DOUBLE CLAMP

    MDR report key: 4974431 · Received August 5, 2015

    Report

    Report Number
    1526350-2015-00137
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 25, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ZIMMER BIOMET SURGICAL
    Product Code
    ILZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT THAT THE OFFSET DOUBLE CLAMP BAR BROKE. THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER CONFIRMED THIS REPORTED INCIDENT. THE CAUSE FOR THE CLAMP TO BREAK WAS A MODIFICATION OF THE CLAMP CASTING BY DRILLING A SECOND THROUGH HOLE. THIS SECOND HOLE WEAKENED THE CLAMP CASTING. IT APPEARS IN THE PHOTOGRAPH THAT THE ADDITIONAL HOLE WAS DRILLED TO ROTATE THE LOCATION OF THE CLAMP JAW. IT IS NOT KNOWN IF THE RE-DRILLING WAS PERFORMED BY ZIMMER (B)(4) OR SUPERB MANUFACTURING AS AN UNAUTHORIZED AND/OR UNDOCUMENTED REWORK TO CORRECT THE CLAMP LOCATION. ADDITIONALLY, IT IS NOT KNOWN IF THE CUSTOMER DRILLED THE EXTRA HOLE TO MODIFY THE CLAMP LOCATION FOR A SPECIFIC USE. THE CAUSE FOR THE COMPONENT FAILURE WAS DUE TO THE ADDITIONAL THROUGH HOLE. THE ROOT CAUSE FOR THE SECOND HOLE IS UNKNOWN. HOWEVER, THE CURRENT SUPPLIER FOR THIS PRODUCT HAS AMENDED THEIR MANUFACTURING INSTRUCTIONS TO ADD A QUALITY CAUTION: "QUALITY CONCERN: IF THE HOLE IS DRILLED IN THE WRONG LOCATION, DO NOT RE-DRILL THE HOLE. THIS WOULD CAUSE THE BAR TO BE WEAKENED AND NO LONGER BE INCOMPLIANCE. THE BAR HAS TO BE SCRAPPED OUT. THIS APPLIES TO ALL BARS WITH HOLES DRILLED THROUGH THEM."

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT GRABBED THE TRAPEZE BAR TO TRANSFER IN BED, THE OFFSET DOUBLE CLAMP BAR BROKE. THE PATIENT WAS HIT BY THE TRACTION SETUP AND THE STAFF MEMBER WAS HIT IN THE HEAD BY THE BROKEN AIRBORNE CLAMP, AND THE HENCE STAFF MEMBER INCURRED INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO INJURY SUSTAINED BY THE PATIENT; HOWEVER THE EMPLOYEE INJURED IN THE INCIDENT WAS TREATED FOR A CONCUSSION BY A NEUROLOGIST. THE EMPLOYEE WAS STATED TO BE RECOVERING AND WAS INITIALLY OFF-WORK FOR THE INJURY; HOWEVER THE EMPLOYEE RETURNED TO WORK REGULAR DUTY AS OF (B)(6) 2015. NO FURTHER INFORMATION REGARDING THE NAME/IDENTIFICATION OF THE EMPLOYEE OR DETAILS OF THE TREATMENT PROVIDED TO THE EMPLOYEE BY THE NEUROLOGIST WERE ABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514944 OFFSET DOUBLE CLAMP OFFSET DOUBLE CLAMP ILZ ZIMMER BIOMET SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1