MAUDE Adverse Event Report: Stryker Endoscopy-San Jose ANGLED AGG. PLUS SHAVER BLADE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5; blade, saw, general & plastic surgery, surgical

Catalog Number	0380544100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that upon attempting to utilize the instrument, and prior to instrument entering patient, the surgeon noted that the instrument was not behaving as normal, and handed instrument back to surgical tech, whom discovered that a portion of the internal cutting mechanism had broken off inside the outer portion of the instrument (the cutting portion of the burr had broken off inside the trocar).All parts remained inside the instrument, and all parts are accounted for.No portion of the instrument went inside the patient during surgery.

• Brand Name: ANGLED AGG. PLUS SHAVER BLADE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5
• Common Device Name: blade, saw, general & plastic surgery, surgical
• 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: 25105291
• Report Number: 0002936485-2026-00284
• Device Sequence Number: 9396820
• Product Code: GFA
• UDI-Device Identifier: 37613327054997
• UDI-Public: (01)37613327054997(17)301029(10)25303CE2
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 0380544100
• Device Lot Number: 25303CE2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown