MAUDE Adverse Event Report: Stryker Endoscopy-San Jose ICONIX 1 WITH INTELLIBRAID TECHNOLOGY 1.4MM ANCHOR WITH 1 STRAND 2 FORCE FIBER; fastener, fixation, nondegradable, soft tissue

Catalog Number	3910-500-512
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the broken tip portion of the iconix remained in the patient's glenoid cavity.
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.

• Brand Name: ICONIX 1 WITH INTELLIBRAID TECHNOLOGY 1.4MM ANCHOR WITH 1 STRAND 2 FORCE FIBER
• Common Device Name: fastener, fixation, nondegradable, soft tissue
• 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 ; +1(408)754-2000
• MDR Report Key: 50488472
• Report Number: 0002936485-2026-00742
• Device Sequence Number: 15980731
• Product Code: MBI
• UDI-Device Identifier: 37613252450338
• UDI-Public: 37613252450338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-500-512
• Device Lot Number: 25262AE2 or 25217AE2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown