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

Model Number	CORING REAMER, 10MM WITH COLLARED PIN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/19/2019
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 requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during an acl procedure, while reaming with the 10mm coring reamer, ar-1224s, the coring reamer began to smoke and then fell apart.This caused a fracture in the femoral condoyle.No further details.Additional information requested.Additional information obtained (b)(6) 2019: facility provided copy of handwritten medwatch report (no report number listed).Facility medwatch report stated the following: a core reamer shattered resulting in lifting a central core of the tibial plateau, causing an intra-articular tibial plateau fracture of the central aspect of the plateau.This required surgical repair.
Additional Manufacturer Narrative
This type of event is likely caused by improper angulation, not centering the coring reamer over the collared pin and/or the use of excessive force.Directions for use (dfu-0070) warns the user that excess drilling force in conjunction with any angulation changes of the reamer during reaming may result in coring reamer deviation or failure of the device.Follow up report also contains additional information obtained on may 29, 2019.
Event or Problem Description
It was reported that during an acl procedure, while reaming with the 10mm coring reamer, ar-1224s, the coring reamer began to smoke and then fell apart.This caused a fracture in the femoral condoyle.No further details.Additional information requested.Additional information obtained 4/26/2019: facility provided copy of handwritten medwatch report (no report number listed).Facility medwatch report stated the following: a core reamer shattered resulting in lifting a central core of the tibial plateau, causing an intra-articular tibial plateau fracture of the central aspect of the plateau.This required surgical repair.Additional information provided 5/29/2019: the surgeon used the coring reamer to break through the cortex instead of an over-sized reamer.

• Brand Name: CORING REAMER, 10MM WITH COLLARED PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8636742
• Report Number: 1220246-2019-01102
• Device Sequence Number: 2091707
• Product Code: LXH
• UDI-Device Identifier: 00888867005648
• UDI-Public: 00888867005648
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CORING REAMER, 10MM WITH COLLARED PIN
• Device Catalogue Number: AR-1224S
• Device Lot Number: 10265703
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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