MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,PEEK,VENT; BONE FIXATION SCREW/PLATE

Model Number	TENO SCRW,PEEK,VENT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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 contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation (discarded at facility).The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the inserter within the screw during use.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
It was reported that during a bio tenodesis procedure, the screw became defective and could not be used.The case was completed by using a new ar-1562ps.

• Brand Name: TENO SCRW,PEEK,VENT
• 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: 19184720
• Report Number: 1220246-2024-02411
• Device Sequence Number: 7232534
• Product Code: HWC
• UDI-Device Identifier: 00888867018914
• UDI-Public: 00888867018914
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: 11/30/2023
• Device Model Number: TENO SCRW,PEEK,VENT
• Device Catalogue Number: AR-1562PS
• Device Lot Number: 10259820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 04/25/2024
• Date Device Manufactured: 12/05/2018
• 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