MAUDE Adverse Event Report: ARTHREX, INC. 45 DEG CURVE LEFT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	45 DEG CURVE LEFT, QUICKPASS LASSO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a glenoid labral lesion repair surgery the tip of the device broke off.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device from another manufacturer (smith&nephew accupass).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-6068-45l batch 3331136720 was received for evaluation.Functional testing was not performed because the device was damaged.Visual evaluation found that the 45° left curve tip was detached at the weld with the shaft.The most likely cause of the observed failure is a use error due to prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: 45 DEG CURVE LEFT, QUICKPASS LASSO
• 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: 18846308
• Report Number: 1220246-2024-01316
• Device Sequence Number: 12702206
• Product Code: LXH
• UDI-Device Identifier: 00888867038929
• UDI-Public: 00888867038929
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/15/2024

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: 45 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-45L
• Device Lot Number: 3331136720
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 08/15/2024
• 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