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 Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
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 the procedure, the surgical cavity was inspected and it was found that the internal distal portion of the blade had fractured and remained inside the cavity.The fragment was carefully removed with forceps, and it was subsequently verified that no residues remained and that no injuries were present in the patient.
Additional Manufacturer Narrative
Alleged failure: found that the internal distal portion of the blade had fractured.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be the blade came in contact with a hard object, causing damaging 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.
Event or Problem Description
It was reported that during the procedure, the surgical cavity was inspected and it was found that the internal distal portion of the blade had fractured and remained inside the cavity.The fragment was carefully removed with forceps, and it was subsequently verified that no residues remained and that no injuries were present in the patient.

• 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 ; 4087542000
• MDR Report Key: 23698179
• Report Number: 0002936485-2025-00961
• Device Sequence Number: 21426585
• Product Code: GFA
• UDI-Device Identifier: 37613327061780
• UDI-Public: 37613327061780
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 24312CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 60 KG