MAUDE Adverse Event Report: ARTHREX, INC. BIO-INTERFERENCE SCREW; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-INTERFERENCE SCREW
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
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 improper bone preparation and/or prying/leveraging the screw during insertion.
Event or Problem Description
On 4/4/2023 it was reported by a distributor via email that an ar-1380b bio-interference screw with disposable sheath had an issue.Ar-4019d-1 fastthread screw driver for 6 mm and ar-1996cd-1 quick connect driver were used to anchor the screw for insertion.However, when the surgeon was screwing it in, the screw did not thread anymore.This was discovered during an lca procedure with no patient harm.Additional information is requested.

• Brand Name: BIO-INTERFERENCE SCREW
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19510994
• Report Number: 1220246-2024-05560
• Device Sequence Number: 3456194
• Product Code: MAI
• UDI-Device Identifier: 00888867015265
• UDI-Public: 00888867015265
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: 08/31/2026
• Device Model Number: BIO-INTERFERENCE SCREW
• Device Catalogue Number: AR-1380B
• Device Lot Number: 15003281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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