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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product broke off into a patient during the procedure.All of the broken pieces were retrieved from the patient.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the product broke off into a patient during the procedure.All of the broken pieces were retrieved from the patient.
Additional Manufacturer Narrative
Alleged failure: product broke off into a patient during the procedure.The failure(s) identified in the investigation are consistent with the complaint record.The probable root cause could be that the blade came in contact with a hard object, causing damage to the teeth and hitting the housing edges.Other possibilities of unintended excessive force applied by the user include bending or prying.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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 ; 4087542000
• MDR Report Key: 23855852
• Report Number: 0002936485-2025-01001
• Device Sequence Number: 20104042
• Product Code: GFA
• UDI-Device Identifier: 37613327054997
• UDI-Public: 37613327054997
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 25176CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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