MAUDE Adverse Event Report: ARTHREX, INC. SUTURE RETRIEVER 3.4MM STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURE RETRIEVER 3.4MM STRAIGHT
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that a ar-12540 suture retrievers jaw broke and will no longer open or close.This occurred during a case, with no patient effect reported.
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 confirmed.One unpackaged ar-12540 -suture retriever 3.4mm serial/batch number (b)(6) was received for investigation.Functional testing found that the device does not function as required.For example, the jaw doesn't move when the finger is powered.Visual evaluation found that the actuator is broken.The cause remains undetermined.

• Brand Name: SUTURE RETRIEVER 3.4MM STRAIGHT
• 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: 15960742
• Report Number: 1220246-2022-05943
• Device Sequence Number: 17530246
• Product Code: LXH
• UDI-Device Identifier: 00888867006461
• UDI-Public: 00888867006461
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/10/2023

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: 14977005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown