MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG, 5MM FEMORAL THREE FLUTED REAMER

Catalog Number	234-020-148
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that during a procedure the instrument broke during an ankle ligament surgery.The incident occurred while creating a tunnel in the ankle.The front of the reamer broke into several pieces.Radiological imaging was done to check for the presence of any potential debris, which confirmed all pieces were removed.

• Brand Name: PKG, 5MM FEMORAL THREE FLUTED REAMER
• Common Device Name: reamer
• Manufacturer (Section D): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 25383080
• Report Number: 0002936485-2026-00353
• Device Sequence Number: 9187998
• Product Code: HTO
• UDI-Device Identifier: 04546540756169
• UDI-Public: 04546540756169
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 234-020-148
• Device Lot Number: 356078
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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