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

Catalog Number	702449
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, the drill broke during use leaving fragments inside the body.In addition to the drill, the guide wire also broke.No further information was provided.
Event or Problem Description
It was reported that, the drill broke during use leaving fragments inside the body.In addition to the drill, the guide wire also broke.No further information was provided.
Additional Manufacturer Narrative
Correction: correction of h6 health impact code.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The returned cannulated tap was inspected and found to be broken at the distal region where the threads are located, with the breakage occurring approximately at the midpoint of the threaded section.Microscopic examination of the breakage surface indicates a brittle failure mode, characterized by the absence of plastic deformation.The observed features suggest that the breakage was primarily caused by the application of excessive torsional and axial loads during use.A dimensional inspection was conducted for the return device, and it was found to be within specification.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 the available information, the root cause can be attributed to a combination of wear and user-related factors.The device has been in use for over 20 years, which has weakened the material integrity over time and through various cleaning and sterilization cycles.Ultimately, breakage occurred due to the application of force.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: 23817134
• Report Number: 0008031020-2025-02160
• Device Sequence Number: 9396203
• Product Code: LXH
• UDI-Device Identifier: 04546540112033
• UDI-Public: 04546540112033
• 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): 02/18/2026

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: Lay User/Patient
• Device Catalogue Number: 702449
• Device Lot Number: D04025
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2003
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male