MAUDE Adverse Event Report: ARTHREX, INC. MICRO SUTRLASSO,TFCC,SHT,70°BEND; ORTHOPEDIC MANUAL SURG INSTR

Model Number	MICRO SUTRLASSO,TFCC,SHT,70°BEND
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
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
It was reported that during an all inside arthroscopic brostrom surgery the device had no action and was not working.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update 29-apr-2024: the lasso inside couldn´t be pulled out of the tool.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, it was noted that the suturelasso, was removed from the device.Functional testing was performed and revealed that the suturelasso passed through the inner diameter of the shaft and handle of the micro suturelasso¿, tfcc, short, 70° bend without any issues.

• Brand Name: MICRO SUTRLASSO,TFCC,SHT,70°BEND
• 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: jared engle ; 8009337001
• MDR Report Key: 19262328
• Report Number: 1220246-2024-02913
• Device Sequence Number: 15082865
• Product Code: LXH
• UDI-Device Identifier: 00888867284920
• UDI-Public: 00888867284920
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 08/16/2024

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: MICRO SUTRLASSO,TFCC,SHT,70°BEND
• Device Catalogue Number: AR-8704-1
• Device Lot Number: 3271135296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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