MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 6MM FEMORAL AIMER; ACCESSORIES, ARTHROSCOPIC

Catalog Number	234-020-046
Medical Device Problem Codes	Material Fragmentation (1261); Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been physically received at stryker endoscopy, usa.Investigation as follows is now based on product received.Alleged failure: device is defective.Visual inspection: the guide broke at the tip and the handle was discolored.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: use of excessive force and improper reprocessing cycles/agents.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device was defective.Based on investigation findings, the inserter tip was broken off.Per additional information received, all pieces were able to be retrieved.

• Brand Name: PKG., 6MM FEMORAL AIMER
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: 24099194
• Report Number: 0002936485-2026-00031
• Device Sequence Number: 10340928
• Product Code: NBH
• UDI-Device Identifier: 07613154174836
• UDI-Public: 07613154174836
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 234-020-046
• Device Lot Number: 750653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown