MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 45 DEGREE, CURVE LEFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURELASSO, 45 DEGREE, CURVE LEFT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 31-jan-2023, it was reported by a sales rep via email that the nitinol wire in an ar-4068-45l, suturelasso, 45 degree, curve left snapped.This was discovered during use and a case was involved.To complete the procedure, a s&n suture shuttle was used.
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
The complaint allegation is confirmed.Per the event description, "on 31-jan-2023, it was reported by a sales rep via email that the nitinol wire in an ar-4068-45l, suturelasso, 45 degree, curve left snapped.It is concluded that the closed wire loop, stranded with a shrink tube, was broken.It is unknown details of the breakages.Visual evaluation of the device dhr for the component (b)(4) pull test requirement ¿wire must withstand a 5 lb.Pull at radius area with force applied at approx.90° in each direction from bend.Found that the lot passed the inspection.The most likely cause can be attributed to use error, as a break can be caused by pulling or adjusting the strands along a sharp or rough edge.No photos were provided.

• Brand Name: SUTURELASSO, 45 DEGREE, CURVE LEFT
• 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: 16386030
• Report Number: 1220246-2023-06302
• Device Sequence Number: 5618189
• Product Code: LXH
• UDI-Device Identifier: 00888867031470
• UDI-Public: 00888867031470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/31/2023

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, 45 DEGREE, CURVE LEFT
• Device Catalogue Number: AR-4068-45L
• Device Lot Number: 1201114157
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 08/31/2023
• 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