MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 2 WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS #2 FORCE F; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was a potential of the inserter on the device breaking during the procedure and potentially remains in the joint.
Event or Problem Description
It was reported that there was a potential of the inserter on the device breaking during the procedure and potentially remains in the joint.
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: device broke during installation.Probable root cause: design inserter shaft and handle design/material too weak.Interface between anchor/guide too tight.Inserter shaft cannot bend around curved guide.Handle lid release force too low process.Inserter and/or guide manufactured out of specification.Anchor coating process out of specification application.Excessive force impacting anchor.Wrong guide selected for anchor.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: ICONIX 2 WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS #2 FORCE F
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10744485
• Report Number: 0002936485-2020-00433
• Device Sequence Number: 17126833
• Product Code: MBI
• UDI-Device Identifier: 37613252450345
• UDI-Public: 37613252450345
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other