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

Model Number	SUTURELASSO, 45 DEGREE, CURVE LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a labrum refixation surgery the tip of the device broke off when piercing the tissue.All parts were retrieved from the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with another device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation was not confirmed.Two sealed packages of ar-4068-45l with the batch number 4003137529 were received for evaluation.However, the devices in question for the complaint allegation were not received for evaluation.Visual inspection found not issues with the returned devices.The outer tube diameter was measure by drawing c4323 at revision.1.Ø.153 ±.001.Results.153 the curved tip was measured by drawing c4313 at revision 0.Ø.073 ±.001 result.073.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 for the reported failure can be attributed to, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: SUTURELASSO, 45 DEGREE, CURVE LEFT
• 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: 19738906
• Report Number: 1220246-2024-06729
• Device Sequence Number: 11685031
• Product Code: LXH
• UDI-Device Identifier: 00888867031470
• UDI-Public: 00888867031470
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/26/2024

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: SUTURELASSO, 45 DEGREE, CURVE LEFT
• Device Catalogue Number: AR-4068-45L
• Device Lot Number: 4003137529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2024
• 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