MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-312
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
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 the fork on the inserter broke and remains in the patient.
Event or Problem Description
It was reported that the fork on the inserter broke and remains in the patient.
Additional Manufacturer Narrative
Alleged failure: good afternoon - i wanted to reach out with some issues we have been having with iconix anchors used in oklahoma city.We are using iconix 1tt in hip scope labral repair cases.Recently we have been seeing forks break off on the inserter and staying implanted in pilot holes, anchors not deploying (even in soft bone), and suture not sliding within the anchor sheeth after deployment.This is one of our largest volume doctors and we are in need of some answers (and possibly a pi#) to address these issues with him.I have attached below the lots and item number below.Additionally, i wanted to make you aware of an issue with flowport (smith & nephew) coming in the packaging disassembled.This happened today and i have attached the photo of the flowport and lot information.*this pi will be split out.Please see pi 2602454 for flowport complaint.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, or 3) use of wrong drill.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT
• 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: 11207556
• Report Number: 0002936485-2021-00044
• Device Sequence Number: 11797361
• Product Code: MBI
• UDI-Device Identifier: 37613327176927
• UDI-Public: 37613327176927
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K170098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 3910-500-312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 03/09/2021
• 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