MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. DRAIN CANNULA 70MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number	0333070001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during initial use.The tip of the obturator broke off when trying to remove the obturator, prior to the procedure.No patient impact.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
The device returned complaint device had the lot number of 25b7576 and the lot number initially reported was 24j6056.Alleged failure: broke during initial use.The tip of the obturator broke off when trying to remove the obturator, prior to the procedure.No patient impact.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) device dropped (within packaging), 2) device dropped (not within packaging), 3) rough handling of the device.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 broke during initial use.The tip of the obturator broke off when trying to remove the obturator, prior to the procedure.No patient impact.

• Brand Name: PKG. DRAIN CANNULA 70MM
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21886648
• Report Number: 0002936485-2025-00370
• Device Sequence Number: 19693655
• Product Code: NBH
• UDI-Device Identifier: 07613327057300
• UDI-Public: 07613327057300
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/02/2025

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: 0333070001
• Device Lot Number: 25B7576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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