BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM DRILL BIT/QC/125MM

    MDR report key: 3964509 · Received July 29, 2014

    Report

    Report Number
    9612488-2014-10308
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWE
    PMA / PMN Number
    PK962913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT/EXPLANT DATE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL PRODUCT CODES: HSZ, GFA, GFF. DEVICE WAS RECEIVED AT MANUFACTURING SITE ON JULY 14, 2014; IT WAS UNKNOWN WHICH COMPLAINT PRODUCT WENT WITH AT THE TIME. ON (B)(4) 2014, IT WAS DETERMINED THE PRODUCT BELONGED WITH THIS COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7332924 OF 2.0MM DRILL BIT/QC/125MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES 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. LIKEWISE, THE RAW MATERIAL LOT USED IN BLANK MANUFACTURE (6895517) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 310.21 LOT 7332924 2.0MM DRILL BIT WAS RECEIVED WITH APPROXIMATELY 15MM OF THE TIP BROKEN OFF AND MISSING. THE REMAINING SHAFT IS BENT 2-3 DEGREES AND PROXIMAL END NOMINALLY WORN WITH ROLL MARKS ON SHAFT LENGTH. THE 310.21 DRILL BIT IS A ROUTINELY USED COMPONENT OF THE SYNTHES SMALL FRAGMENT SYSTEM AND LIKELY WAS PROVIDED AND USED IN CONJUNCTION WITH THE SYNTHES MODULAR FOOT SYSTEM WHICH PROVIDES IMPLANTS AND INSTRUMENTS SPECIFICALLY SIZED FOR FRACTURES, OSTEOTOMIES, REPLANTATIONS AND FUSIONS OF SMALL BINES INCLUDING THE FOOT AND ANKLE. THE DRILL IS RECOMMENDED SIZE FOR PREDRILLING FOR THE 2.7MM CORTEX SCREW HOLES. AS THE TIP IS MISSING, IT IS NOT POSSIBLE TO DETERMINE THE SHARPNESS AND SUITABILITY FOR USE OF THE DRILL HOWEVER, THE BENT CONDITION DEMONSTRATES THE RESULT OF THE SIGNIFICANT FORCE APPLIED TO THE DELICATE 2MM DRILL BIT TO PERMIT SUCH BENDING. GENERALLY, THE CUTTING DESIGN OF A SUITABLY SHARP DRILL BIT WOULD ALLEVIATE THE NEED TO APPLY SUCH FORCES TO THE DRILL TIP. IT IS LIKELY THAT EXCESSIVE FORCE WAS APPLIED TO THE DRILL BIT AS A RESULT OF A DULL CUTTING RESULTED IN THE TIP BREAKING AND THIS COMPLAINT. IN USE COLLISION MAY ALSO HAVE CONTRIBUTED TO THIS COMPLAINT. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. IT IS NECESSARY TO INSPECT ALL SUCH DEVICES BEFORE REUSE TO DETERMINE SHARPNESS AND SUITABILITY FOR NEXT USE AS EXPRESSED IN SYNTHES TECHNIQUE GUIDES, PACKAGED INSTRUCTIONS FOR USE AND WEB GUIDES. THE METHOD OF USE, EXCESSIVE FORCE, WEAR AND POSSIBLE COLLISION HAS LED TO THIS CONFIRMED COMPLAINT AND IS NOT THE RESULT OF A PERCEIVED DESIGN DEFICIENCY. 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 DURING INITIAL USE FOR A BUNION LEFT FOOT BUNION SURGERY ON (B)(6), 2014 A 2.0MM FLUTED DRILL BIT BROKE OFF IN THE PATIENT'S FOOT. THE BROKEN PORTION REMAINS IN THE PATIENT. THE PATIENT'S OUTCOME WAS NOTED AS NOT YET DETERMINED AS THE BROKEN DRILL BIT FRAGMENT MAY BECOME SYMPTOMATIC IN THE FUTURE; THE DRILL BIT MAY HAVE MIGRATED INTO THE PERONEAL LONGUS TENDON. MULTIPLE ATTEMPTS TO LOCATE AND REMOVE THE DRILL BIT FRAGMENT FAILED INCLUDING FLUOROSCOPY AND TRIANGULATION, EXTENDING THE OPERATING TIME TO ONE HOUR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440893 2.0MM DRILL BIT/QC/125MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES ELMIRA 7332924

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention