MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM; BONE FIXATION SCREW/PLATE

Model Number	BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
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 (b)(6) 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 prying/leveraging the device during use.
Event or Problem Description
On (b)(6) 2022, it was reported by an arthrex employee via email that an ar-1547cds biocomposite-tenodesis screw could not fix down the graft, which cause the graft to fall out.A new product was used and case was completed without further issues.This was discovered during a procedure on (b)(6) 2022.Additional information received on 7/13/2022: this was discovered during a reconstruction of all of the knee.This occurred two consecutively times with the same ar-1547cds biocomposite-tenodesis screw.Nothing broke inside the patient and case was completed using a device from another manufacturer.

• Brand Name: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• 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: 19232319
• Report Number: 1220246-2024-02723
• Device Sequence Number: 6882638
• Product Code: HWC
• UDI-Device Identifier: 00888867233959
• UDI-Public: 00888867233959
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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: 08/31/2023
• Device Model Number: BIO-COMP-TENOD SCRW W/DISP DRV 4.75X15MM
• Device Catalogue Number: AR-1547CDS
• Device Lot Number: 14088256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2021
• 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