MAUDE Adverse Event Report: STRYKER GMBH 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING; BIT, DRILL

Catalog Number	45-30005S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the tip of the hollow drill was damaged due to drilling with flexure.".
Additional Manufacturer Narrative
The received pictures were reviewed and it can be confirmed that the drill bit is strongly deformed and partially broken at the forefront.It looks like the drill bit cannot be removed from the also visible drill guide anymore due to this damage.However, there is no indication that the drill guide did contribute to the damage of the drill bit.This is also indicated by the event description, where it is stated that lateral stress (flexure) was applied, which can lead to a breakage of this cannulated drill bit.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.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the tip of the hollow drill was damaged due to drilling with flexure.".

• Brand Name: 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22805305
• Report Number: 0008031020-2025-01371
• Device Sequence Number: 9063410
• Product Code: HTW
• UDI-Device Identifier: 04546540534217
• UDI-Public: (01)04546540534217(17)290923(10)6000108788
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/12/2025

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: 45-30005S
• Device Lot Number: AQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown