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	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2020
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.
Event or Problem Description
It was reported during an acl reconstruction the tip of the reamer expanded and produced shards of metal.A shaver was used to distract as much of the metal debris as possible.The doctor did not do an x-ray to insure all metal was recovered and the rep is not 100% confident all was retrieved.The rest of the case was completed without issue.

• 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: 10483716
• Report Number: 1220246-2020-02124
• Device Sequence Number: 1246018
• Product Code: LXH
• UDI-Device Identifier: 00888867005648
• UDI-Public: 00888867005648
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/02/2020

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: 10/31/2024
• Device Model Number: CORING REAMER, 10MM WITH COLLARED PIN
• Device Catalogue Number: AR-1224S
• Device Lot Number: 10448398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/02/2020
• 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