MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AGG. PLUS SHAVER BLADE F-SERIES 5.0MM EACH - ORDER MULTIPLES OF 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375554000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a small piece of the teeth from the shaver blade broke off in middle of case.The physician cleaned the joint up using a new shaver blade and the small metal tooth was suctioned up using another shaver blade.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Alleged failure: a small piece of the teeth from the shaver blade broke off in middle of case the failure(s) identified in the investigation are consistent with the complaint record.The probable root cause of these issues could be the inner tube impacting the housing edges and/or the blade coming into contact with a hard object.The product was returned for investigation, and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that a small piece of the teeth from the shaver blade broke off in middle of case.The physician cleaned the joint up using a new shaver blade and the small metal tooth was suctioned up using another shaver blade.

• Brand Name: AGG. PLUS SHAVER BLADE F-SERIES 5.0MM 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: 23688587
• Report Number: 0002936485-2025-00959
• Device Sequence Number: 15809656
• Product Code: GFA
• UDI-Device Identifier: 37613327061889
• UDI-Public: 37613327061889
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 01/20/2026

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: 0375554000
• Device Lot Number: 24302CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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 Sex: Unknown