MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5 MM; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
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.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 when tensioning the sutures.
Event or Problem Description
Using the 3.5 pushlock ar-1926ps-1 for second row suture.The sutures were loaded into the implant and it was punched into the bone.When pulling the anchor out the sutures came with it and the screw stayed in the bone.A new pushlock needed to be opened and a new hole created to complete repair.

• Brand Name: SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5 MM
• 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: 19247970
• Report Number: 1220246-2024-02807
• Device Sequence Number: 17972110
• Product Code: MAI
• UDI-Device Identifier: 00888867023345
• UDI-Public: 00888867023345
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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 Model Number: SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5 MM
• Device Catalogue Number: AR-1926PS-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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