MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT Ø2.5MM X 285MM, AO; SCREW, FIXATION, BONE

Catalog Number	703586
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During drilling to fix the proximal outer plate of the axos tibia, the drill broke in contact with the screw.The broken tip was inside the patient's tibia and could not be removed.The doctor continued the surgery to complete.
Additional Manufacturer Narrative
The reported event that calibrated drill bit ø2.5mm x 285mm, ao was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate angulation during drilling.The device inspection revealed the following: the tip of the returned drill is indeed completely broken / snapped off.The close up views, done by the microscope is indicating that the surface of the breakage is homogenous which again indicate conformity to the given specification.Therefore we can state that the root cause of the failure was caused due to inadequate angulation during drilling, as the drill tip came in contact with a screw which resulted in the tip breakage (powerful dynamically overload during use).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During drilling to fix the proximal outer plate of the axos tibia, the drill broke in contact with the screw.The broken tip was inside the patient's tibia and could not be removed.The doctor continued the surgery to complete.

• Brand Name: CALIBRATED DRILL BIT Ø2.5MM X 285MM, AO
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7732849
• Report Number: 0008031020-2018-00526
• Device Sequence Number: 13707807
• Product Code: HWC
• UDI-Device Identifier: 04546540694089
• UDI-Public: 04546540694089
• Combination Product (Y/N): N
• PMA/510(K) Number: K133440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 703586
• Device Lot Number: KU83827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other