MAUDE Adverse Event Report: ARTHREX, INC. NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET; SCREW, FIXATION, BONE

Model Number	NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/28/2022, it was reported by a sales representative via email that an ar-8998t nano swivelock broke prematurely.This was discovered during a thumb ucl repair on (b)(6) 202022.Case was completed using 8 2.5mm mini pushlock anchors.Additional information requested.
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: NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Common Device Name: SCREW, FIXATION, BONE
• 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: 13839437
• Report Number: 1220246-2022-04611
• Device Sequence Number: 12215507
• Product Code: HWC
• UDI-Device Identifier: 10888867301822
• UDI-Public: 10888867301822
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191651
• 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): 03/21/2022

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 Expiration Date: 06/30/2026
• Device Model Number: NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Device Catalogue Number: AR-8998T
• Device Lot Number: 13707017
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/21/2022
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown