MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX DC GUIDE FOR 1.4MM ANCHOR; ACCESSORIES, ARTHROSCOPIC

Catalog Number	3910500580
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
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 in a hip scope, it was noticed two anchors deployed that were damaged from the guide in a very unusual manner.The doctor mentioned the tip of the guide felt sharp and looked broken.After examination, a part of the tip of the guide had broken leaving a sharp edge to damage suture.All broken pieces were retrieved.
Additional Manufacturer Narrative
Multiple attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house for evaluation.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: tip of the guide felt sharp and looked broken.Probable root cause: application: -excessive force on guide.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that in a hip scope, it was noticed two anchors deployed that were damaged from the guide in a very unusual manner.The doctor mentioned the tip of the guide felt sharp and looked broken.After examination, a part of the tip of the guide had broken leaving a sharp edge to damage suture.All broken pieces were retrieved.

• Brand Name: ICONIX DC GUIDE FOR 1.4MM ANCHOR
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22178171
• Report Number: 0002936485-2025-00525
• Device Sequence Number: 8842471
• Product Code: NBH
• UDI-Device Identifier: 07613327634686
• UDI-Public: 07613327634686
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/27/2025

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: 3910500580
• Device Lot Number: 403294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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