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

Model Number	3911-714-520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
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, "dr.(b)(6) utilized the reusable iconix 1.4mm drill and cycled it a few times to make a pilot hole for the iconix knotless implant (pn 3911714520).The implant failed to insert into the hole.The inserter buckled during the insertion attempt, bending the guide near its distal tip.The tip of the inserter broke during the insertion attempt and was subsequently retrieved and removed from the patient.The shuttle suture frayed when passed with the nanopass.None of the implant, nor its inserter was left in 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 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.

• Brand Name: ICONIX KNOTLESS
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 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: 18007149
• Report Number: 3006981798-2023-00071
• Device Sequence Number: 7677954
• Product Code: MBI
• UDI-Device Identifier: 00840277402172
• UDI-Public: 00840277402172
• Combination Product (Y/N): N
• 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?: No
• Is this a Product Problem Report?: No
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/25/2023
• 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
• Patient Sex: Unknown