MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM; PLATE, FIXATION, BONE

Model Number	AGK10070
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that drill bit axsos 3 ti non-locking, short, ø2.5 x 216mm 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 to too much applied mechanical force.The device inspection revealed the following: the returned drill bit is indeed completely broken off.The metal surface of the drill shaft is badly damaged (torsional deformation) in several spots which clearly indicates that far too much force had been applied during use.The same can be said from the tip.The tip as well as the point of breakage ( a bit below the helix) are very badly deformed / damaged, which indicates possibly inadequate handling during use (due to too much mechanical force).A review of the device history for the reported lot did not indicate any abnormalities.Nevertheless, note that a corrective (b)(4) has been initiated in order to address this occurrence.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 axsos surgery, the drill bit was broken inside the patient's bone when drilling from outside.The patient suffered another small incision to removed the broken piece of the drill bit.The drill bit was completely removed from the patient.The surgery was continued with another drill bit.

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7245429
• Report Number: 0008031020-2018-00090
• Device Sequence Number: 1028138
• Product Code: HRS
• UDI-Device Identifier: 07613252257875
• UDI-Public: (01)07613252257875(10)00751V
• Combination Product (Y/N): N
• PMA/510(K) Number: K141121
• 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
• Report Date (Section B): 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AGK10070
• Device Catalogue Number: 705025
• Device Lot Number: 00751V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/06/2018
• 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: Required Intervention
• Patient Age: 42 YR