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	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during insertion of the anchor, one of the prongs of the insertion device broke off within the bone.The piece was potentially left in patient.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
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.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 during insertion of the anchor, one of the prongs of the insertion device broke off within the bone.The piece was potentially 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20057891
• Report Number: 0002936485-2024-00598
• Device Sequence Number: 15399705
• Product Code: MBI
• UDI-Device Identifier: 37613252450345
• UDI-Public: 37613252450345
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 3910-500-522
• Device Lot Number: 23130AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White