MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ANGLED TOMCAT SHAVER BLADE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0380545100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
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 surgeon was using an arthroscopic shaver blade during a right knee arthroscopy.The surgeon noted tiny metal fragments on the monitor inside the patient's knee.The surgeon determined the metal fragments were from the shaver blade.The surgeon removed the shaver blade from the knee and a new shaver blade was used without further incident.The knee was irrigated at the end of the surgery.
Event or Problem Description
It was reported that surgeon was using an arthroscopic shaver blade during a right knee arthroscopy.The surgeon noted tiny metal fragments on the monitor inside the patient's knee.The surgeon determined the metal fragments were from the shaver blade.The surgeon removed the shaver blade from the knee and a new shaver blade was used without further incident.The knee was irrigated at the end of the surgery.
Additional Manufacturer Narrative
The complaint device was reported to have been discarded.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: tiny fragment inside patient's knee probable root cause: foreign material left in the device stains corrosion inadequate cleaning process environmental conditions dents scratches shipping damage the reported failure mode will be monitored for future reoccurrence.

• Brand Name: ANGLED TOMCAT 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22387627
• Report Number: 0002936485-2025-00614
• Device Sequence Number: 15198305
• Product Code: GFA
• UDI-Device Identifier: 37613327055031
• UDI-Public: 37613327055031
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 0380545100
• Device Lot Number: 24124CE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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