MAUDE Adverse Event Report: ARTHREX, INC. SECONDARY FIXATION KIT, ACL/PCL REPAIR; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SECONDARY FIXATION KIT, ACL/PCL REPAIR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/20/2021 it was reported by a arthrex employee via email that an ar-1593 became stuck during insertion.The surgeon attempted to cut the tap with a drill to fix the thread but the inserter broke.This was discovered during use in a meniscal repair on 08/17/2021.The case was completed with a new ar-1593.
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.Complaint confirmed.The anchor threads were found to be damaged.Additional damage was observed on the driver tube.The most likely causes include improper bone prep, misaligned insertion, prying and/or leveraging the device during insertion.

• Brand Name: SECONDARY FIXATION KIT, ACL/PCL REPAIR
• 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: 19330083
• Report Number: 1220246-2024-03378
• Device Sequence Number: 19602076
• Product Code: MAI
• UDI-Device Identifier: 00888867258686
• UDI-Public: 00888867258686
• Combination Product (Y/N): N
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 06/30/2022
• Device Model Number: SECONDARY FIXATION KIT, ACL/PCL REPAIR
• Device Catalogue Number: AR-1593
• Device Lot Number: 11402253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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