MAUDE Adverse Event Report: RIVERPOINT MEDICAL ICONIX KNOTLESS; FIXATION DEVICE

Model Number	3911-714-520
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and therefore was not returned.A review of the device history record was performed and all product met requirements prior to release.Investigation is still ongoing.No cause for the event has been established at this time.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "(1.6mm arthrex drill from disposable kit ar-3600dc) implant inserted.During the shuttling step the shuttle got "stuck" right were the beginning of the tucked shuttle loop is entering the fingertrap mechanism in the iconix knotless implant.The surgeon repeatedly tried to finish the shuttling, but eventually broke the shuttle tail in this attempt.The remaining strands were cut and the anchor remained in the patient.After the surgery it was noticed that the inserter for iconix knotless inserter #2 was missing one of the 2 fork tips.The surgeon was notified.There is a potential that the inserter fork tip was implanted into the patient.".
Additional Manufacturer Narrative
The device was discarded and therefore was not returned.A review of the device history record was performed and all product met requirements prior to release.Investigation determined that the instructions for use needed more clarity.This report and use of categorical definitions required by fda 3500a does not constitute an admission by (b)(6) medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.

• Brand Name: ICONIX KNOTLESS
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 17980969
• Report Number: 3006981798-2023-00069
• Device Sequence Number: 3470533
• Product Code: MBI
• UDI-Device Identifier: 00840277402172
• UDI-Public: 00840277402172
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K231278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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 Expiration Date: 07/31/2025
• Device Model Number: 3911-714-520
• Device Lot Number: 23080433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 300698179810/25/2023001C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown