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 Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: during stryker iconix 2,3 implant placement the anchor got loose and it was not embedded in the bone, another implant was used in the same canal.Implant was retrieved from patient body.Visual inspection: the flat tip was bent and the fork tip broke off.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) movement of guide out of orientation to pilot hole, 3) use of wrong drill.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during implant placement, the anchor got loose and it was not embedded in the bone, another implant was used in the same canal.Implant was retrieved from patient body.There were no device fragments left in patient.

• 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 ; 4087542000
• MDR Report Key: 24099195
• Report Number: 0002936485-2026-00030
• Device Sequence Number: 16037428
• Product Code: MBI
• UDI-Device Identifier: 37613252450345
• UDI-Public: 37613252450345
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 01/16/2026

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: 3910-500-522
• Device Lot Number: 24341AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White