MAUDE Adverse Event Report: ARTHREX, INC. DISPS KIT,TRANS-TIB ACL W/O SAWBLD; MANUAL INSTR, GENERAL SURGICAL

Model Number	DISPS KIT,TRANS-TIB ACL W/O SAWBLD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 1/24/2024, an fda medwatch notification was received via email.An anonymous nurse reported that the guidewire from an ar-1898s transtibial acl disposables kit was noted to be broken into two pieces during the procedure.All the broken fragments were removed with no apparent injury.This was discovered during a left arthroscopic aclr procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: e.1: initial reported updated.G.3: follow-up information received.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded the most likely cause.The most likely cause of the reported failure is user error, specifically misalignment during insertion and/or excessive force during insertion.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: DISPS KIT,TRANS-TIB ACL W/O SAWBLD
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 18730283
• Report Number: 1220246-2024-01019
• Device Sequence Number: 8264023
• Product Code: MDM
• UDI-Device Identifier: 00888867022461
• UDI-Public: 00888867022461
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

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 Model Number: DISPS KIT,TRANS-TIB ACL W/O SAWBLD
• Device Catalogue Number: AR-1898S
• Device Lot Number: 15166361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 02/26/2024; 05/13/2025
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/13/2024; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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