BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 5067308 · Received September 10, 2015

    Report

    Report Number
    1719045-2015-10590
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE PRODUCT CODES ARE GFF, GFA AND HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS INITIAL REPORTER HOSPITAL CONTACT PHONE NUMBER ¿ (B)(6). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION / PRODUCT INVESTIGATION WAS PREFORMED: THE COMPLAINT CONDITION FOR THE 310.25 LOT NUMBER U203198 2.5MM DRILL BIT WAS LIKELY CAUSED BY A COLLISION WITH SOMETHING HARDER THAN BONE DURING DRILLING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS CONDITION IS CONFIRMED; THERE IS A HOMOGENOUS FRACTURE SURFACE APPROXIMATELY EIGHT MILLIMETERS FROM THE BEGINNING OF THE FLUTING AT THE DISTAL END OF THE DEVICE. IT IS LIKELY THAT THE DEVICE CAME INTO CONTACT WITH SOMETHING HARDER THAN BONE WHILE DRILLING LEADING TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN 6/2014 AND IS OVER A YEAR OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIR CONDITION WITH SOME MARKINGS AT THE PROXIMAL END. DEVICE DRAWING(S) WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4): SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT A DRILL BIT BROKE INTO THE PATIENT'S TIBIA AND THE TIP WAS LEFT IN THE PATIENT'S BONE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIA PROCEDURE. THERE WAS A REPORTED FIVE MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600935 2.5MM DRILL BIT/QC/GOLD/110MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACHMENTS HWE SYNTHES MONUMENT U203198

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention