MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS

Catalog Number	705025S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
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 not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that when the drill bit was broken during drilling.Therefore, it was changed the new same one and the operation was succeeded.All broken piece was removed from the patient body.

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM
• Common Device Name: SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8356290
• Report Number: 0008031020-2019-00072
• Device Sequence Number: 1914815
• Product Code: HWE
• UDI-Device Identifier: 07613327083439
• UDI-Public: 07613327083439
• Combination Product (Y/N): N
• 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): 02/20/2019

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 705025S
• Device Lot Number: 10994Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/20/2019
• 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