BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL, DIAM.1.4X94MM, WL 27MM, WITH STOP, STRYKER SHAFT, STERILE PACKED

    MDR report key: 4120551 · Received September 26, 2014

    Report

    Report Number
    0008010177-2014-00278
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE BROKEN DRILL COULD BE CONFIRMED. THE DRILL TIP OF THE TWIST DRILL IS BROKEN OFF AND HAS NOT BEEN RETURNED FOR INVESTIGATION (SEE INVESTIGATION IMAGE DOCUMENTATION). THE VISUAL INVESTIGATION OF THE TWIST DRILL REVEALED THAT THE DRILL TIP IS BROKEN AT THE BEGINNING OF THE WORK LENGTH. THE SHAFT SHOW A FRICTION MARK. THE FRACTURE SURFACE SHOWS THE APPEARANCE OF AN DUCTILE FORCED RUPTURE. BASED ON THE USAGE OF THE DRILL SPEED OF 40,000 RPM, WHICH IS 40 TIMES HIGHER THAN THE MAXIMAL ALLOWED ROTATION SPEED BY THE INSTRUCTION FOR USE, THE DRILL BIT BROKE DUE TO THE HIGH ECCENTRIC FORCES CAUSED BY THE HIGH ROTATION SPEED. FURTHERMORE, IT CAN BE NOTED THE REFERENCED DEVICES TYPICALLY HAVE A DENTAL SOCKET, AS ALSO THE RETURNED DRILL BIT OF INVESTIGATION (B)(4). THE INDICATION THAT THE SAME DEVICE HAS BEEN USED FOR BOTH DRILL BITS (OF THIS INVESTIGATION AND INVESTIGATION #(B)(4)) AND THE FOUND FRICTION MARK ON THE SHAFT IN THE TYPICAL AREA OF THE END OF THE TOOL HOLDER, IT CAN BE CONCLUDED THAT THE DRILL BIT OF THIS INVESTIGATION WAS USED WITH THE WRONG TOOL HOLDER AND THAT THE MISFIT CONTRIBUTED TO ECCENTRIC MOVEMENTS OF THE DRILL BIT AND FINALLY TO THE BREAKAGE OF THE DEVICE. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE SURGEON, THAT IN PREPARATION FOR A SURGICAL PROCEDURE (OPEN REDUCTION / INTERNAL FIXATION OF THE PROXIMAL PHALANX) THE SURGEON TESTED THE DRILL TO ENSURE THAT THE DEVICE WAS RUNNING CORRECTLY PRIOR TO ITS USE ON THE PATIENT AND THAT THE DRILL BIT ALLEGEDLY BROKE OFF AND STRUCK HIS FACE. THE CUSTOMER REPORTED THAT HE DID NOT SUSTAIN AN INJURY AS A RESULT OF THE IMPACT AS HE WAS WEARING A FACE MASK. THE CUSTOMER REPORTED THAT HE THEN REPLACED THE BROKEN BIT WITH A NEW BIT AND THAT WHEN HE STARTED UP THE DRILL ONCE AGAIN TO TEST THAT THE DEVICE WAS RUNNING CORRECTLY THIS SECOND DRILL BIT ALLEGEDLY BENT. THE SURGEON FURTHER NOTED THAT DURING THESE PRE-USE TESTS, THE DRILL BITS WERE NOT IN CONTACT WITH ANY OTHER OBJECT WHILE THEY WERE RUNNING WHICH COULD HAVE CAUSED THE BIT TO BREAK OR BEND. THE CUSTOMER CONFIRMED THAT BOTH BITS WERE NEW, OUT OF THE PACKET, AND THAT BOTH APPEARED TO BE NORMAL ON VISUAL INSPECTION PRIOR TO BEING INSERTED INTO THE ATTACHMENT ON THE HANDPIECE. THE CUSTOMER REPORTED THAT THERE WERE NO PARTICULAR NOISES OR OTHER WARNING SIGNS TO SIGNAL THAT THE DRILL BITS MAY BREAK WHILE THE DRILL WAS RUNNING FREELY. IT IS NOT KNOWN AT THIS STAGE THE SPEED AT WHICH THE DRILL WAS RUNNING WHEN THE REPORTED EVENT OCCURRED. THE CUSTOMER HAS YET TO PROVIDE DETAILS OF THE HANDPIECE ATTACHMENT THAT WAS BEING USED IN CONJUNCTION WITH THE REPORTED DRILL BITS. THE CUSTOMER ALSO REPORTED THAT SURGERY WAS COMPLETED SUCCESSFULLY BY CHOOSING A DIFFERENT DRILL AND BY USING A SMALLER DRILL BIT AND A SMALLER SCREW.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE SURGEON, THAT IN PREPARATION FOR A SURGICAL PROCEDURE (OPEN REDUCTION / INTERNAL FIXATION OF THE PROXIMAL PHALANX) THE SURGEON TESTED THE DRILL TO ENSURE THAT THE DEVICE WAS RUNNING CORRECTLY PRIOR TO ITS USE ON THE PATIENT AND THAT THE DRILL BIT ALLEGEDLY BROKE OFF AND STRUCK HIS FACE. THE CUSTOMER REPORTED THAT HE DID NOT SUSTAIN AN INJURY AS A RESULT OF THE IMPACT AS HE WAS WEARING A FACE MASK. THE CUSTOMER REPORTED THAT HE THEN REPLACED THE BROKEN BIT WITH A NEW BIT AND THAT WHEN HE STARTED UP THE DRILL ONCE AGAIN TO TEST THAT THE DEVICE WAS RUNNING CORRECTLY THIS SECOND DRILL BIT ALLEGEDLY BENT. THE SURGEON FURTHER NOTED THAT DURING THESE PRE-USE TESTS, THE DRILL BITS WERE NOT IN CONTACT WITH ANY OTHER OBJECT WHILE THEY WERE RUNNING WHICH COULD HAVE CAUSED THE BIT TO BREAK OR BEND. THE CUSTOMER CONFIRMED THAT BOTH BITS WERE NEW, OUT OF THE PACKET, AND THAT BOTH APPEARED TO BE NORMAL ON VISUAL INSPECTION PRIOR TO BEING INSERTED INTO THE ATTACHMENT ON THE HANDPIECE. THE CUSTOMER REPORTED THAT THERE WERE NO PARTICULAR NOISES OR OTHER WARNING SIGNS TO SIGNAL THAT THE DRILL BITS MAY BREAK WHILE THE DRILL WAS RUNNING FREELY. IT IS NOT KNOWN AT THIS STAGE THE SPEED AT WHICH THE DRILL WAS RUNNING WHEN THE REPORTED EVENT OCCURRED. THE CUSTOMER HAS YET TO PROVIDE DETAILS OF THE HANDPIECE ATTACHMENT THAT WAS BEING USED IN CONJUNCTION WITH THE REPORTED DRILL BITS. THE CUSTOMER ALSO REPORTED THAT SURGERY WAS COMPLETED SUCCESSFULLY BY CHOOSING A DIFFERENT DRILL AND BY USING A SMALLER DRILL BIT AND A SMALLER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600701 TWIST DRILL, DIAM.1.4X94MM, WL 27MM, WITH STOP, STRYKER SHAFT, STERILE PACKED INSTRUMENT HTW STRYKER LEIBINGER FREIBURG 1000004000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other