MAUDE Adverse Event Report: ARTHREX, INC. AVN DISPOSABLES KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AVN DISPOSABLES KIT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via (b)(6) that during use of an ar-3519h kit, the surgeon was inserting the reamer into the femoral tunnel, the blade deployed halfway of the intended distance, and would not retract.The surgeon removed the reamer, with the blade deployed.This was discovered during use in a avn surgical procedure on (b)(6) 2021.The case was completed opening a new ar-3519h.Additional information: 12/08/2021 on (b)(6) 2021, it was reported by a sales representative via email that during use of an ar-3519h kit, the surgeon was inserting the reamer into the femoral tunnel, the intended socket size at that part of the case was a 5mm tunnel.The blade was deployed all the way out to 15 creating a trough in the tunnel that was not intended.This issue probably added 20 min to the case since we had to re-position the guide to create a new bone tunnel path.No additional incisions were made.
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.
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
On (b)(6) 2021, it was reported by a sales representative via (b)(6) that during use of an ar-3519h kit, the surgeon was inserting the reamer into the femoral tunnel, the blade deployed halfway of the intended distance, and would not retract.The surgeon removed the reamer, with the blade deployed.This was discovered during use in a avn surgical procedure on (b)(6) 2021.The case was completed opening a new ar-3519h.Additional information: 12/08/2021 on (b)(6) 2021, it was reported by a sales representative via email that during use of an ar-3519h kit, the surgeon was inserting the reamer into the femoral tunnel, the intended socket size at that part of the case was a 5mm tunnel.The blade was deployed all the way out to 15 creating a trough in the tunnel that was not intended.This issue probably added 20 min to the case since we had to re-position the guide to create a new bone tunnel path.No additional incisions were made.
Additional Manufacturer Narrative
This follow-up for 1220246-2021-04208 is to update and change section b1 to adverse event from the initial submission of product problem.Also, section h1, the type of reportable event is now "serious injury" change from "malfunction" in the original submission of 1220246-2021-04208.

• Brand Name: AVN DISPOSABLES KIT
• 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: 13087959
• Report Number: 1220246-2021-04208
• Device Sequence Number: 5085106
• Product Code: LXH
• UDI-Device Identifier: 00888867266643
• UDI-Public: 00888867266643
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: AVN DISPOSABLES KIT
• Device Catalogue Number: AR-3519H
• Device Lot Number: 13075818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/19/2022
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown