MAUDE Adverse Event Report: ARTHREX, INC. CAPSULESTITCH SUTURE PASSER

Model Number	CAPSULESTITCH SUTURE PASSER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
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
It was reported on (b)(6) 2023 by a sales representative via sems that an ar-7070 capsule stitch suture passer peek tubing broke inside the joint.Case involvement, the device broke during use.

• Brand Name: CAPSULESTITCH SUTURE PASSER
• Common Device Name: PASSER
• 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: 16501076
• Report Number: 1220246-2023-06395
• Device Sequence Number: 6129275
• Product Code: HWQ
• UDI-Device Identifier: 10818674027141
• UDI-Public: 10818674027141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/08/2023

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: CAPSULESTITCH SUTURE PASSER
• Device Catalogue Number: AR-7070
• Device Lot Number: 22P03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/08/2023
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown