MAUDE Adverse Event Report: Stryker Endoscopy-San Jose ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY 2.3MM ANCHOR WITH 2 STRANDS 2 FORC; fastener, fixation, nondegradable, soft tissue

Catalog Number	3910-500-422
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 a 2.3mm iconix needle was used in the surgery.After the preparation of pilot hole by using the dedicated disposable drill in the same package, the anchor was malleted through the drill guide.However, after pulling out the handle of the anchor, it was found that the distal part of the shaft was bent and one of the tips was also broken and left in the patient.The surgeon spent about 10 mins to find the broken tip in the patient, and redeploy another new anchor.There¿s no other impact to the patient.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY 2.3MM ANCHOR WITH 2 STRANDS 2 FORC
• 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: 50462580
• Report Number: 0002936485-2026-00725
• Device Sequence Number: 10263818
• Product Code: MBI
• UDI-Device Identifier: 37613327283434
• UDI-Public: 37613327283434
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K173074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 3910-500-422
• Device Lot Number: 25148AE2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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