MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE COBRA SUTURE PASSER CAPTURE; ACCESSORIES, ARTHROSCOPIC

Catalog Number	3910-900-093
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that a broken needle occurred during a case.All broken pieces were removed, and the case was completed successfully.No adverse effects to patient.There was a 10 minute delay.
Additional Manufacturer Narrative
Alleged failure: needle breaking.Confirmed failure: bent needle.Probable root cause: application.Attempt to use the device with broken or bent needle, attempt to pass through thick tissue or bone, excessive tissue loaded into jaws, lack of due care when inserting instrument into soft tissue, use of excessive force, attempt to load or pass incompatible suture, technique error, improper reprocessing cycles, agents used; reprocessing instructions not followed.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that a broken needle occurred during a case.All broken pieces were removed, and the case was completed successfully.No adverse effects to patient.There was a 10 minute delay.

• Brand Name: COBRA SUTURE PASSER CAPTURE
• 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: 23373956
• Report Number: 0002936485-2025-00871
• Device Sequence Number: 8894427
• Product Code: NBH
• UDI-Device Identifier: 07613327413595
• UDI-Public: 07613327413595
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/02/2026

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: 3910-900-093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 03/02/2026
• 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