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

Model Number	SUTRLASSO SD SFT,45°RT CRV,R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
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 (b)(6) 2023, it was reported by an arthrex employee via sems that an ar-5068-45r suturelasso sd shaft broke when the surgeon used the device the second time in the procedure.The case was completed successfully and with no piece breaking inside the patient.This was discovered during a meniscus repair procedure on (b)(6) 2023, with no patient harm.Additional information requested on (b)(6) 2023: the case was completed using a non-arthrex product with no delay in the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-5068-45r serial/batch number (b)(6) was received for investigation.Visual evaluation found that the tip was broken off.Functional testing was not conducted due to the damage to the instrument's tip.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: SUTRLASSO SD SFT,45°RT CRV,R
• 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: 17559452
• Report Number: 1220246-2023-07513
• Device Sequence Number: 4801540
• Product Code: LXH
• UDI-Device Identifier: 00888867035621
• UDI-Public: 00888867035621
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/04/2024

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: 0072238
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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