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	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tip of the inserter broke off, leaving fragments in the patient's bone.
Additional Manufacturer Narrative
The customer confirmed that the device will not be returned for investigation.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: inserter broken, material fragmentation.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.
Event or Problem Description
It was reported that the tip of the inserter broke off, leaving fragments in the patient's bone.

• 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 ; 4087542000
• MDR Report Key: 23139111
• Report Number: 0002936485-2025-00795
• Device Sequence Number: 21055046
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-500-512
• Device Lot Number: 24243AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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