MAUDE Adverse Event Report: ARTHREX, INC. QUAD TENDON STRIPPER- CUTTER; MANUAL INSTR, GENERAL SURGICAL

Model Number	QUAD TENDON STRIPPER- CUTTER
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
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 3/7/2024, it was reported by a sales representative via (b)(4) that an ar-2384 quad tendon stripper-cutter blade was not cutting the tendon and seemed to be loose within the mechanism.The case was completed by returning to using an 11-blade with no adverse effect on the patient.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed, upon visual inspection, it was found that the stripper blade had chipped and worn, also, the cutter blade had spots of corrosion.During functional testing, it was observed that the stop mechanism would get stuck during actuation.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Per dfu-0023-eo rev 4 e.Inspection and maintenance 2.Devices with cutting functions or sharp points become dull with continuous use.This condition does not indicate a device defect.This condition indicates normal wear.Dull devices may require replacement if they no longer perform as designed.Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges.3.To protect instruments from staining and rusting, lubricate all moving parts prior to packaging and sterilization with an instrument lubricant that is biocompatible and has given compatibility with steam sterilization up to 138°c (280°f).Apply lubricants in accordance with manufacturer¿s instructions.Re-lubrication is critical for devices that contain actuating mechanisms (e.G.Ratcheting handles) to ensure continued effective operation.

• Brand Name: QUAD TENDON STRIPPER- CUTTER
• 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: 18960584
• Report Number: 1220246-2024-01644
• Device Sequence Number: 20846019
• Product Code: MDM
• UDI-Device Identifier: 00888867098244
• UDI-Public: 00888867098244
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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 Model Number: QUAD TENDON STRIPPER- CUTTER
• Device Catalogue Number: AR-2384
• Device Lot Number: 012331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown