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	08/08/2018
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
It was reported that when the distal hole was drilling with drill (703586) after proximal hole was drilling , tip of the drill was broken and remained in the patient bone.
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 too much applied mechanical force.The device inspection revealed the following: the tip of the returned drill bit is indeed completely broken off.Whereas it is clearly visible that high applied forces led to a strain hardening / embrittlement of the material which finally resulted in the breakage (over time).Such power, in combination with hard/dense bone could definitely deform the drill bit and lead to such a breakage.Particularly, if the drilling was in an inclined angle or hard bone, a bending moment could be generated, leading to a fracture of the drill bit, as the one reported.The root cause of the failure was repeated powerful dynamically overload during use.Note that the drill was manufactured in nov.2013.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
It was reported that when the distal hole was drilling with drill (703586) after proximal hole was drilling, tip of the drill was broken and remained in the patient bone.

• 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: 7848601
• Report Number: 0008031020-2018-00587
• Device Sequence Number: 11045250
• 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: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: KU80602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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
• Patient Age: 56 YR