MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC ICONIX KNOTLESS; HARD BONE DRILL BIT FIR 1.4MM ICONIX KNOTLESS

Model Number	3911-714-571
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned as it was discarded and there were no retains available for review.Review of the dhr confirmed that all product requirements were met prior to release.The correct drill bit was used per the buildsheet.Raw material lot gqj247601 was used in finished goods lot 25121901, and per the coc met all requirement, including material composition, visual and dimensional criteria, and hardness upon receipt.There was no evidence that the device failed to meet specifications and the report could not substantiated.The ifu for this device (pub470) was reviewed and determined to have sufficient instructions and warnings regarding the use of and risks associated with this device.A cause for the event cannot be established.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 has cause or contributed to the event described in the report.Riverpoint medical 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 fda.
Event or Problem Description
According to the reporter, "surgeon was about to put the first anchor in the patient and the pa did the drilling, big part of the tip of the drill broke inside the patient and couldn't take it out.After the first anchor completely pulled out after inserting it, we tried drilling in another spot that had better bone.I noticed that the drill went straight in and out without any resistance so the tech took out the drill and noticed the tip was clearly snapped off.We took an xray after to see if it was inside the patient and it was.We tried seeing if we could find a tip to maybe remove it but it ended up being buried in bone so stayed there.Surgeon was very upset and just ended up putting in another anchor instead of 2 more.".

• Brand Name: ICONIX KNOTLESS
• Common Device Name: HARD BONE DRILL BIT FIR 1.4MM ICONIX KNOTLESS
• 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 ; 5035178001
• MDR Report Key: 25325582
• Report Number: 3006981798-2026-00025
• Device Sequence Number: 9985657
• Product Code: HTW
• UDI-Device Identifier: 00840277402592
• UDI-Public: 00840277402592
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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?: Yes
• Device Model Number: 3911-714-571
• Device Lot Number: 25121901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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
• Patient Sex: Unknown