BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT/QC/125MM

    MDR report key: 3790295 · Received May 5, 2014

    Report

    Report Number
    3003506883-2014-10046
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWE
    PMA / PMN Number
    PK962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAMES: HSZ, GFA, GFF. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.0MM DRILL BITS WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REWORK OR NONCONFORMITIES. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014, THE RESIDENT WAS ATTEMPTING TO DRILL FOR A 2.7MM VARIABLE ANGLE LOCKING SCREW WHEN HE CROSSED THE PATH OF A PREVIOUSLY PLACED SCREW. THE DRILL BIT BROKE AS A RESULT OF BEING BENT DURING THE DRILLING PHASE. APPROXIMATELY 2CM WAS RETAINED IN THE DISTAL TIBIA (PILON) REGION OF THE PATIENT. THE ATTENDING DID NOT WANT TO TRY TO RETRIEVE THE FRAGMENT; THEREFORE, A PIECE OF AN INSTRUMENT REMAINED IN THE PATIENT AFTER SURGERY. ADDITIONAL MEDICAL INTERVENTION IS NOT REQUIRED. SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266865 2.0MM DRILL BIT/QC/125MM INSTR, SURGICAL, ORTHOPEDIC, AC HWE SYNTHES ELMIRA 7296193

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR