MAUDE Adverse Event Report: ARTHREX, INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	REAMER, LOW PROFILE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
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 reamer broke upon coming in contact with the bone while the surgeon was attempting to drill a tibial tunnel.One wing of the broken reamer was located and the other was not.An x-ray was used to scan the patient's leg and no metal fragments were located.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified and confirmed the distal tip of the reamer had fractured.All pieces were retrieved from the patient and, without the return of the device, further investigation cannot be performed.The root cause of the reported failure is undetermined.

• Brand Name: REAMER, LOW PROFILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11800855
• Report Number: 1220246-2021-03049
• Device Sequence Number: 16418736
• Product Code: LXH
• UDI-Device Identifier: 00888867016699
• UDI-Public: 00888867016699
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 09/01/2021

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: REAMER, LOW PROFILE
• Device Catalogue Number: AR-1407LP-50
• Device Lot Number: 11505016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 09/01/2021
• Patient Sequence Number: 1