MAUDE Adverse Event Report: STRYKER GMBH CANNULATED DRILL ASNIS III Ø2.7MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702449
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the drill bit broke in two.".
Event or Problem Description
As reported: "the drill bit broke in two.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned broken.The device inspection revealed the following: the device was returned fractured at its tip.The fragment was not returned.The cutting flutes appear blunted and smoothed, they are not sharp anymore, which evidences intensive usage overtime.Near the fracture area, the tip and cutting flutes show plastic deformation rather than a sharp fracture face.This indicates the drill broke in a ductile manner, due to torsional overload.Most likely the blunt and worn-out cutting flutes resulted in excessive torque during use, leading to torsional overload and therefore breakage of the device.Relevant dimensions were measured and were conforming to specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused by excessive torque applied during use, with prolonged service life as a contributing factor.In this relation, the instructions for use state the following: ensure that drilling and cutting tools are sharp.In addition, the stryker instructions for cleaning, sterilization, inspection and maintenance provides information to identify when the device should no longer be reused or is still within specification.If more information is provided, the case will be reassessed.

• Brand Name: CANNULATED DRILL ASNIS III Ø2.7MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23137842
• Report Number: 0008031020-2025-01633
• Device Sequence Number: 9831880
• Product Code: LXH
• UDI-Device Identifier: 04546540112033
• UDI-Public: (01)04546540112033(10)16580Y
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 702449
• Device Lot Number: 16580Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2019
• 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