MAUDE Adverse Event Report: ARTHREX, INC. SUTRLASSO FOR HIP,45°CRV R; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTRLASSO FOR HIP,45°CRV R
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
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
On 10/4/2022, it was reported by a sales representative via sems that an ar-4068-45lh suturelasso¿ for hip arthroscopy 45° curve left and an ar-4068-45rh suturelasso¿ for hip arthroscopy 45° curve right had an issue.During a hip arthroscopy / labral repair on (b)(6) 2022, both wired lassos into the above two products broke easily under a very small amount of pull/traction.This occurred upon wires passage to shuttle sutures.A piece broke from the devices and the broken pieces were fully retrieved.Nothing additional had to be done, and the procedure was completed successfully.This was discovered during use with no impact to the patient.

• Brand Name: SUTRLASSO FOR HIP,45°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: 15657297
• Report Number: 1220246-2022-05640
• Device Sequence Number: 6377179
• Product Code: LXH
• UDI-Device Identifier: 00888867031500
• UDI-Public: 00888867031500
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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 Expiration Date: 01/31/2025
• Device Model Number: SUTRLASSO FOR HIP,45°CRV R
• Device Catalogue Number: AR-4068-45RH
• Device Lot Number: 0041101186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/24/2022
• Date Device Manufactured: 02/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown