MAUDE Adverse Event Report: ARTHREX, INC. CORING REAMER, 10MM WITH COLLARED PIN; PLATE, FIXATION, BONE

Model Number	CORING REAMER, 10MM WITH COLLARED PIN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the metal at the leading edge of the reamer mushroomed when it was drilled into the bone during an acl case.It went from 10 mm to 24 mm.It stopped before it hit the joint; there was a hairline fracture in the tibia.The patient was male, (b)(6) years.

• Brand Name: CORING REAMER, 10MM WITH COLLARED PIN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11871773
• Report Number: 1220246-2021-03130
• Device Sequence Number: 1009800
• Product Code: LXH
• UDI-Device Identifier: 00888867005648
• UDI-Public: 00888867005648
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: CORING REAMER, 10MM WITH COLLARED PIN
• Device Catalogue Number: AR-1224S
• Device Lot Number: 10079696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other