MAUDE Adverse Event Report: ARTHREX, INC. CORING REAMER, 10MM WITH COLLARED PIN; ORTHOPEDIC MANUAL SURG INSTR

Model Number CORING REAMER, 10MM WITH COLLARED PIN

Device Problem Material Deformation (2976)

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

Event Date 02/14/2024

Event Type  malfunction  

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.

Event Description

On (b)(6) 2024, it was reported by an arthrex subsidiary employee via sems (b)(4) that the surgeon has used the coring reamer, ar-1224s, in many cases and is familiar with the technique.He followed the procedure to drill the tibial tunnel and upon exiting into joint, the tip of the coring reamer expanded and flowered open.There are multiple splits in the reamer near the tip.He was able to remove the drill and no remains were inside the joint.The issue was noticed after the device exited the cavity.There was no adverse effect on the patient.

• Brand Name: CORING REAMER, 10MM WITH COLLARED PIN
• 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: 18816265
• MDR Text Key: 336659296
• Report Number: 1220246-2024-01234
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CORING REAMER, 10MM WITH COLLARED PIN
• Device Catalogue Number: AR-1224S
• Device Lot Number: 15112500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2023
• 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