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

Model Number OSTEOAUGER BONE GRAFT HARVESTER, 6MM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/20/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 293863566
• Report Number: 1220246-2022-05053
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867377042
• UDI-Public: 00888867377042
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/23/2022
• Date Device Manufactured: 11/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other