MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 90 DEGREE STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURELASSO, 90 DEGREE 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	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by an arthrex employee via email that an ar-4068-90 suturelasso tip was damaged while inside the patient.A new product was used to complete the case.This was discovered during an unspecified procedure on (b)(6) 2022.
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 confirmed.One unpackaged ar-4068-90 serial/batch number ukn was received for investigation.Visual inspection found that the suturelasso, sd, 90° straight tip was broken off at the distal end of the shaft.No fragments were returned for analysis.Multiple discoloration spots were observed on the device's shaft.The root cause of the reported failure mode is undetermined; however, the observed event is most likely caused by excessive bending forces applied during use.

• Brand Name: SUTURELASSO, 90 DEGREE 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: 15788209
• Report Number: 1220246-2022-05739
• Device Sequence Number: 4754297
• Product Code: LXH
• UDI-Device Identifier: 00888867031517
• UDI-Public: 00888867031517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/13/2023

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: SUTURELASSO, 90 DEGREE STRAIGHT
• Device Catalogue Number: AR-4068-90
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown