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

Model Number	10MM TENDON STRIPPER BLADE
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a quad autograft acl procedure the blade would not click into the handle.It was replaced and the case was completed with no further issues.
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 is not confirmed.One unpackaged ar-2385-10, batch 21c02 tendon stripper was received for investigation.Dimensional analysis of the proximal end of the shaft where the tendon stripper interfaces with the handle identified that the returned device was within tolerance.The handle itself was not returned for analysis.As such, the allegation cannot be verified.No problem found.

• 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: 19172377
• Report Number: 1220246-2024-02301
• Device Sequence Number: 18006326
• Product Code: MDM
• UDI-Device Identifier: 00888867098268
• UDI-Public: 00888867098268
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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: 02/28/2026
• Device Model Number: 10MM TENDON STRIPPER BLADE
• Device Catalogue Number: AR-2385-10
• Device Lot Number: 21C02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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