MAUDE Adverse Event Report: ARTHREX, INC. 10MM TENDON STRIPPER BLADE; MANUAL INSTR, GENERAL SURGICAL

Model Number	10MM TENDON STRIPPER BLADE
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
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.Complaint confirmed.Three unpackaged ar-2385-10 blades were received for investigation.Functional testing with an ar-2383 identified that none of the three blades were able to be fitted in place.Each of the blades was also noted to be warped and scuffed, most likely as a result of attempts to fit them into place along the handle instrument.Refer to (b)(4) for further details.
Event or Problem Description
It was reported that during a quad tendon anterior cruciate ligament reconstruction the knife (10mm, ar-2385-10) will not fit on the quad handle instrument (ar-2383).With a lot of force the knife will go on the inserter and also to get it off the handle is not easy.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 10MM TENDON STRIPPER BLADE
• 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: 19569923
• Report Number: 1220246-2024-06199
• Device Sequence Number: 6963480
• Product Code: MDM
• UDI-Device Identifier: 00888867098268
• UDI-Public: 00888867098268
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• 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): 06/19/2024

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: 04/30/2026
• Device Model Number: 10MM TENDON STRIPPER BLADE
• Device Catalogue Number: AR-2385-10
• Device Lot Number: 21E10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown