MAUDE Adverse Event Report: ARTHREX, INC. SUTURE RETRIEVER 3.4MM STRAIGHT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE RETRIEVER 3.4MM STRAIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/09/2023, it was reported by an arthrex employee via sems that an ar-12540 suture retriever broke.This occurred during an arthroscopic repair of the left rotator cuff on 03/07/2023 when it was noticed that the front end of the device was broken.The procedure was completed using a device from a different manufacturer.There was no additional information provided.Additional information has been 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.
Additional Manufacturer Narrative
Complaint is not confirmed.Upon visual evaluation, no broken parts were observed on the device.Also, notice that the jaws did not work as required (open/close).This is typically caused by excessive force while grasping and manipulating tissue or using excessive leveraging forces.The cause remains undetermined.Functional testing was performed noticed that the device did not work as required.

• Brand Name: SUTURE RETRIEVER 3.4MM STRAIGHT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 16618646
• Report Number: 1220246-2023-06500
• Device Sequence Number: 17665738
• Product Code: LXH
• UDI-Device Identifier: 00888867006461
• UDI-Public: 00888867006461
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: SUTURE RETRIEVER 3.4MM STRAIGHT
• Device Catalogue Number: AR-12540
• Device Lot Number: 10231577
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown