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

Catalog Number	3910-500-522
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after drill hole was prepared using a 2.3mm drill and the anchor was impacted into the bone, the inserter shaft was removed and found the tip was missing.The missing tip was about 1mm and cannot be found on table.It was believed that the tip was left in the anchor, which was inside the patient's glenoid intrabony.The doctor thought that the metal piece was fixed inside bone and decided to continue the surgery without removing it.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that after drill hole was prepared using a 2.3mm drill and the anchor was impacted into the bone, the inserter shaft was removed and found the tip was missing.The missing tip was about 1mm and could not be found on table.It was believed that the tip was left in the anchor, which was inside the patient's glenoid intrabony.The doctor thought that the metal piece was fixed inside bone and decided to continue the surgery without removing it.
Additional Manufacturer Narrative
Product was not received in-house at stryker endoscopy.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 missing.Probable root cause: application, excessive force impacting inserter, movement of guide out of orientation to pilot hole, use of wrong drill.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: ICONIX 2 WITH INTELLIBRAID TECHNOLOGY 2.3MM ANCHOR WITH 2 STRANDS 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: 25487285
• Report Number: 0002936485-2026-00380
• Device Sequence Number: 15935278
• Product Code: MBI
• UDI-Device Identifier: 07613252450344
• UDI-Public: (01)07613252450344(17)271013(10)25286AE2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 3910-500-522
• Device Lot Number: 25286AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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