MAUDE Adverse Event Report: ARTHREX, INC. SUTURING SET, PROTECTOR MENISCUS; MANUAL INSTR, GENERAL SURGICAL

Model Number	SUTURING SET, PROTECTOR MENISCUS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
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 complaint cannot be confirmed based on the customer provided photo, which displays the undamaged device.No change in harm was identified.
Event or Problem Description
On 05/02/2022, it was reported by a arthrex employee via sems that a ar-9803-90 ablator, and a ar-4060s suturing set malfunctioned.This occurred on 04/22/2022 during an unknown procedure when using the ar-9803-90 the tip melted into the shape of a j, it was used at a temperature of 60/60.When using the protector, the doctor had to force the thread through as it was getting stuck.There was no patient effect reported.Additional information provided on 05/13/2023, it was reported that this event occurred during a resection of clavicle/rotator cuff rupture/labral injury.There was no patient effect, or injury due to this incident.The case was completed by unsenting the tip while it was hot and used it only once to finish.But it remained soft even when lowering the scalpel temperature to 40 l 40.

• Brand Name: SUTURING SET, PROTECTOR MENISCUS
• 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: 19310755
• Report Number: 1220246-2024-03237
• Device Sequence Number: 7009936
• Product Code: MDM
• UDI-Device Identifier: 00888867031302
• UDI-Public: 00888867031302
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 05/14/2024

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: 01/31/2026
• Device Model Number: SUTURING SET, PROTECTOR MENISCUS
• Device Catalogue Number: AR-4060S
• Device Lot Number: 1018109402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2021
• 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