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

Model Number	QUAD TENDON STRIPPER- CUTTER
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/17/2024, it was reported by a facility representative via sems-(b)(4) that an ar-2384 quad tendon stripper cutter was not sharp enough.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One unpackaged ar-2384 batch 012416 was received for evaluation.Upon visual inspection, it was observed that the cutting circle has nicks and is slightly bent.Functional testing could not be conducted because the damaged to the cutting edge.The most likely cause of the reported failure is user error, which can involve actions such as applying excessive force during use or mishandling the device.

• 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: 19918191
• Report Number: 1220246-2024-07043
• Device Sequence Number: 7602306
• Product Code: MDM
• UDI-Device Identifier: 00888867098244
• UDI-Public: 00888867098244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: 012416
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2024
• 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