MAUDE Adverse Event Report: ARTHREX, INC. CORING REAMER, 9MM WITH COLLARED PIN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	CORING REAMER, 9MM WITH COLLARED PIN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-1223s coring reamer was damaged, no additional information was provided.This was discovered during use with no impact to the patient.Additional information has been requested.On (b)(6) 2022, the sales representative stated the following information via phone: this event occurred during an acl reconstruction procedure on (b)(6) 2022.When drilling the tibia, the reamer broke inside the tibia.All fragments were retrieved and the case was completed successfully with no impact to the patient.
Additional 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: CORING REAMER, 9MM WITH COLLARED PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14194562
• Report Number: 1220246-2022-04805
• Device Sequence Number: 17454314
• Product Code: LXH
• UDI-Device Identifier: 00888867005532
• UDI-Public: 00888867005532
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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 Model Number: CORING REAMER, 9MM WITH COLLARED PIN
• Device Catalogue Number: AR-1223S
• Device Lot Number: 14915822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/25/2022
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown