MAUDE Adverse Event Report: ARTHREX, INC. SUTRLASSO FOR HIP,90°STR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTRLASSO FOR HIP,90°STR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
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
On 06/30/2023, it was reported by a sales representative via sems that an ar-4068-90h sutur1220246-2023-07349 elasso broke.This occurred during a case, the fragments were retrieved.The case was completed.There was no additional information provided, additional information has been requested.
Event or Problem Description
07/12/2023, received response with additional information: what type of case did this occur in? - hip scope.How did the device break? - wire lasso broke while surgeon was pulling it through joint.How was the case completed? - used the same product with a new lot number.Was there any effect on the patient? - no.
Additional Manufacturer Narrative
Additional info: b5 event updated.H6 updated.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is attributed to misuse due to prying/leveraging the device during use.

• Brand Name: SUTRLASSO FOR HIP,90°STR
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17417408
• Report Number: 1220246-2023-07349
• Device Sequence Number: 9025350
• Product Code: LXH
• UDI-Device Identifier: 00888867031524
• UDI-Public: 00888867031524
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/07/2025

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 FOR HIP,90°STR
• Device Catalogue Number: AR-4068-90H
• Device Lot Number: 0044101306
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 01/16/2025
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 02/20/2024; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown