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

Catalog Number	0375544000
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
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 during shaver operation, the tip fractured and fell into the patient¿s shoulder joint cavity.The surgeon retrieved the broken fragments and removed them promptly.No missing parts of the cutter head were found after inspection, and a new device was used thereafter.This incident prolonged the operative duration.

• Brand Name: 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: 25601879
• Report Number: 0002936485-2026-00398
• Device Sequence Number: 12145879
• Product Code: GFA
• UDI-Device Identifier: 37613327061780
• UDI-Public: (01)37613327061780(17)300327(10)25087CE2
• 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: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 0375544000
• Device Lot Number: 25087CE2
• Was Device Available for Evaluation?: No
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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