MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, SHORT, 3.1 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	705031S
Medical Device Problem Codes	Device Damaged by Another Device (2915); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: " the drill bit was crimped to the drill sleeve during use and could not be removed.The drill bit was new.".
Event or Problem Description
As reported: " the drill bit was crimped to the drill sleeve during use and could not be removed.The drill bit was new.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The device inspection revealed the following: the drill and the drill sleeve were found to be stuck with each other.The drill portion, outside the sleeve, showed heavy circular marks caused due the drill making contact with the sleeve edge under intense usage with a power drill.There was no clearance/play between the drill and the sleeve.However, after the disassembly with much effort, it was found that the area of drill inside the sleeve was also scuffed due to contact with the sleeve.After disassembling, a functional inspection was performed.The drill was not able to pass through the sleeve.A resistance could be felt during insertion, due to the constriction in the sleeve¿s cannulation at the exit.The drill was found to be within specifications upon a dimensional inspection.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause of the jamming is user related.The drill under intense usage, interacted with the sleeve, causing severe deformation to both the drill and the sleeve, leading to jamming.If any further information is provided, the complaint report will be updated.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, 3.1 X 216MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11121368
• Report Number: 0008031020-2021-00010
• Device Sequence Number: 19002239
• Product Code: HWE
• UDI-Device Identifier: 07613327083330
• UDI-Public: 07613327083330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 01/31/2025
• Device Model Number: 705031S
• Device Catalogue Number: 705031S
• Device Lot Number: 17735D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1