MAUDE Adverse Event Report: ARTHREX, INC. OSTEOAUGER BONE GRAFT HARVESTER, 6MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OSTEOAUGER BONE GRAFT HARVESTER, 6MM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that while harvesting bone from the calcaneus of a patient using an abs-8000-06 8mm osteo-auger, patient experienced bone burning.Surgeon down sized to a 6mm osteo-auger and was able to complete the desired diameter along with saline irrigation to decrease the amount of bone burning.This was discovered during a procedure on (b)(6) 2022.
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: OSTEOAUGER BONE GRAFT HARVESTER, 6MM
• 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: 14674272
• Report Number: 1220246-2022-05053
• Device Sequence Number: 4791400
• Product Code: LXH
• UDI-Device Identifier: 00888867377042
• UDI-Public: 00888867377042
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/13/2022

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 Model Number: OSTEOAUGER BONE GRAFT HARVESTER, 6MM
• Device Catalogue Number: ABS-8000-06
• Device Lot Number: 14470076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/13/2022
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown