BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM

    MDR report key: 4997708 · Received August 12, 2015

    Report

    Report Number
    1719045-2015-10506
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER, 357.403, STEPPED CANNULATED DRILL BIT, LOT NUMBER 203116). THE SUBJECT DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN AT THE TIP DURING SURGERY. THIS CONDITION IS CONFIRMED; THE DISTAL PORTION OF THE DRILL BIT IS FRACTURED ALONG A JAGGED EDGE. IT IS LIKELY THAT THE DRILL BIT CAME INTO CONTACT WITH THE GUIDE WIRE OR SOMETHING HARDER THAN BONE 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 FAIRLY WORN CONDITION WITH THE DISTAL EDGES OF THE DRILL BIT DULLED CONSIDERABLY. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. 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

    DHR REVIEW ¿ (B)(4) MANUFACTURED THE 6.0MM / 10.0MM STEPPED DRILL BIT CANNULATED / LARGE / QC / 435MM, P/N 357.403, LOT # U203116, DATED (B)(6) 2014. THE CERTIFICATE OF CONFORMANCE INDICATED THE LOT CONFORMED TO THE MATERIAL, HARDNESS, AND SPECIFICATIONS. THE LOT CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE LOT WAS RELEASED TO THE WAREHOUSE ON (B)(6) 2014. 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

    ADDITIONAL NARRATIVE: PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    IT WAS REPORTED THAT A STEPPED CANNULATED DRILL BIT, BROKE DURING SURGERY AND FRAGMENTS WERE LEFT IN PATIENT BONE. SURGERY WAS DELAYED BY TEN (10) MINUTES. IT WAS REPORTED THAT TIP OF DRILL BIT BROKE DURING RETROGRADE FEMORAL NAILING PROCEDURE. SURGEON TRIED TO RETRIEVE THE BROKEN TIP BUT HE WAS UNSUCCESSFUL. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528833 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM REAMER HTO SYNTHES MONUMENT U203116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention