MAUDE Adverse Event Report: ARTHREX, INC. 8MM SINGLE USE OATS DISPOSABLE KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number 8MM SINGLE USE OATS DISPOSABLE KIT

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

On 02/20/2024, it was reported by a sales representative via (b)(4) that an abs-8981-08s disposables kit 13mm positive stop reamer was not sharp, and therefore was not engaging into bone.The surgeon switched to the 8mm depth reamer, which worked great.This occurred during use in a case with no patient effect.

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.

• Brand Name: 8MM SINGLE USE OATS DISPOSABLE KIT
• Type of Device: 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: 18838257
• MDR Text Key: 336925766
• Report Number: 1220246-2024-01300
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867343870
• UDI-Public: 00888867343870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8MM SINGLE USE OATS DISPOSABLE KIT
• Device Catalogue Number: ABS-8981-08S
• Device Lot Number: 2355127737
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1