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

Model Number	BIO-COM INTERFERENCE SCREW, TAPERED TIP
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2022
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 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 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.
Event or Problem Description
On 10/20/2022, it was reported by a sales representative via email that (2) ar-1360c biocomposite interference screw had an issue with the threading that did not allow the screw to advance.It was difficult to tell if two independent threads were joined or if the first thread were smaller than normal, would not engage.This was discovered during a procedure on (b)(6) 2022.Additional information received on 10/21/2022: this was discovered during an mcl procedure and was completed by fixating an onlay using an ar-2324bcc-2 bio composite swivelock instead of inlay with the interference screw.Additional information requested.

• Brand Name: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• 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: 19238762
• Report Number: 1220246-2024-02760
• Device Sequence Number: 8072647
• Product Code: MAI
• UDI-Device Identifier: 00888867014008
• UDI-Public: 00888867014008
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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: 02/28/2026
• Device Model Number: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Device Catalogue Number: AR-1360C
• Device Lot Number: 14941861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2022
• 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