MAUDE Adverse Event Report: ARTHREX, INC. 10 MM SINGLE USE OATS SET; ORTHOPEDIC MANUAL SURG INSTR

Model Number	10 MM SINGLE USE OATS SET
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/07/2021 it was reported by an arthrex employee via email that an ar-1981-10s transfer system oats device bent during an ankle surgery.The surgeon completed the procedure using a new device with the same part number.There was no patient effect reported.Additional information provided on 12/30/2021 : the calcaneus receptor sample was to be taken from the patient.Sclerotic bone is performed at the time of inserting the device to prepare the receiving area, the edges are bent and nicked.
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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Per initial complaint report, device was discarded by the facility.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during insertion.

• Brand Name: 10 MM SINGLE USE OATS SET
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19331484
• Report Number: 1220246-2024-03403
• Device Sequence Number: 12513420
• Product Code: LXH
• UDI-Device Identifier: 00888867025356
• UDI-Public: 00888867025356
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 05/16/2024

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: 10 MM SINGLE USE OATS SET
• Device Catalogue Number: AR-1981-10S
• Device Lot Number: 1008109145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown