MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	705031S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device was discarded.
Event or Problem Description
During axsos dt surgery, the drill bit stuck inside the drill sleeve after the drilling.The surgeon removed the drill bit from the sleeve by force, soft tissue had been entangled to the drill.When the surgeon removed the drill bit from the sleeve, the patient bone scraped a little extra.After that the procedure continued without problem.
Additional Manufacturer Narrative
Correction: section d4 (lot #).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Based on given information, the root cause was attributed to be user related.The failure was caused by possible inadequate use.Nevertheless 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 record 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
During axsos dt surgery, the drill bit stuck inside the drill sleeve after the drilling.The surgeon removed the drill bit from the sleeve by force, soft tissue had been entangled to the drill.When the surgeon removed the drill bit from the sleeve, the patient bone scraped a little extra.After that the procedure continued without problem.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8799477
• Report Number: 0008031020-2019-00833
• Device Sequence Number: 2484763
• Product Code: HWE
• UDI-Device Identifier: 07613327083330
• UDI-Public: 07613327083330
• 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,Followup
• Report Date (Section B): 08/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 705031S
• Device Lot Number: 13101Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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