MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, CORKSCREW
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Visual evaluation of photos provided by the customer identified that the anchor tip of the device had fractured.However, without the return of the device, further investigation cannot be performed.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.
Event or Problem Description
It was reported that during a rotator cuff procedure, when the surgeon was implanting the ar-1920sf, the anchor rolled and was removed from the patient.The case was completed by using a new ar-1920sf.Images attached.

• Brand Name: SUTURE ANCHOR, CORKSCREW
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19449361
• Report Number: 1220246-2024-04753
• Device Sequence Number: 3278057
• Product Code: HWC
• UDI-Device Identifier: 00888867022829
• UDI-Public: 00888867022829
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: SUTURE ANCHOR, CORKSCREW
• Device Catalogue Number: AR-1920SF
• Device Lot Number: 12804678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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