MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AGG. PLUS SHAVER BLADE SMALL JOINT F-SERIES 3.5MM EACH - ORDER MULTIPLES; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375638000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: stryker small joint cutter break while being used on a patient.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause of the failure could be excessive force applied by the user, such as bending or prying, which may lead to the bending or breaking of the arthroscopic shaver blades.Additionally, the blade may have come into contact with a hard object, which could have damaged the teeth and impacted the housing edges.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported during a case, 1 of the stryker small joint cutter broke while being used on a patient, the surgical team were able to remove the bit that broke.
Additional Manufacturer Narrative
Alleged failure: stryker small joint cutter break while being used on a patient the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause of the failure could be excessive force applied by the user, such as bending or prying, which may lead to the bending or breaking of the arthroscopic shaver blades.Additionally, the blade may have come into contact with a hard object, which could have damaged the teeth and impacted the housing edges.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported during a case, 1 of the stryker small joint cutter broke while being used on a patient, the surgical team were able to remove the bit that broke.

• Brand Name: AGG. PLUS SHAVER BLADE SMALL JOINT F-SERIES 3.5MM EACH - ORDER MULTIPLES
• 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: 22913332
• Report Number: 0002936485-2025-00737
• Device Sequence Number: 15758452
• Product Code: GFA
• UDI-Device Identifier: 37613327061995
• UDI-Public: 37613327061995
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 0375638000
• Device Lot Number: 23124CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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