MAUDE Adverse Event Report: ARTHREX, INC. SUTRLASSO SD SFT,45°RT CRV,R; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTRLASSO SD SFT,45°RT CRV,R
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	01/12/2023
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 01/12/2023 by a sales representative via sems that an ar-5068-45r suture lasso needle broke off.Case involvement, device broke during use.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-5068-45r suturelasso, 45° right curve serial/batch number (b)(6) was received for investigation.Functional testing not performed due to that the instrument was broken.Upon visual evaluation the instrument hook/tip was broken off.The fragments generated during the event were not returned for analysis.The root cause of the reported failure mode is undetermined.However, the most probable cause is applying excessive mechanical forces upon insertion/use.

• Brand Name: SUTRLASSO SD SFT,45°RT CRV,R
• 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: 16263830
• Report Number: 1220246-2023-06193
• Device Sequence Number: 7518608
• Product Code: LXH
• UDI-Device Identifier: 00888867035621
• UDI-Public: 00888867035621
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/14/2023

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: SUTRLASSO SD SFT,45°RT CRV,R
• Device Catalogue Number: AR-5068-45R
• Device Lot Number: 0071942
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown