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

Model Number	NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 21st march 2024, it was reported by a sales rep.Via email that for an ar-8998t, nano swivelock® suture anchor with fork eyelet, the screwdriver part of the inserter broke off on insertion of anchor.This was detected during an unspecified procedure on (b)(6) 2024.25th march 2024 - the sales rep.Replied that this was detected during use in a ucl procedure.The procedure was completed successfully as the other driver from the other swivelock was used but also became damaged.4th april 2024 - the sales rep.Replied that the other driver was also damaged as it was bent.However, the procedure was completed successfully as they made do with the bent driver.The surgeon was not happy and wanted a singly wrapped spare string driver.
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 complaint allegation is confirmed based on the photo provided by the customer.Visual evaluation revealed the tip of the driver is bent.Arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to over-torquing the screw when inserting into the plate and/or hard bone.

• Brand Name: NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19126834
• Report Number: 1220246-2024-02092
• Device Sequence Number: 7641066
• Product Code: HWC
• UDI-Device Identifier: 10888867301822
• UDI-Public: 10888867301822
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Model Number: NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Device Catalogue Number: AR-8998T
• Device Lot Number: 15043416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown