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

Catalog Number	0375555000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Cartilage damage (4833)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during the procedure.Please note that while this resulted in reported cartilage damage, there was no additional medical intervention required and no surgical delay due to this.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke during the procedure.Please note that while this resulted in reported cartilage damage, there was no additional medical intervention required and no surgical delay due to this.
Additional Manufacturer Narrative
Alleged failure: the customer reported to the sales rep that: "we had an issue yesterday with the stryker shaver blade, ref.(b)(4), during a procedure on a knee.The blade became detached and injured the patient's cartilage." the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be: 1)the shaver blade may not have been inserted properly into the hand piece.2)excessive force or improper use by the user may have caused the shaver blade to become detached from the hand piece.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: TOMCAT 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20972873
• Report Number: 0002936485-2024-00968
• Device Sequence Number: 12852406
• Product Code: GFA
• UDI-Device Identifier: 37613327061865
• UDI-Public: 37613327061865
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 0375555000
• Device Lot Number: 24078CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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