MAUDE Adverse Event Report: ARTHREX, INC. 90 DEG CURVE RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	90 DEG CURVE RIGHT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
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
It was reported that during a rotator cuff surgery, the lasso was not able to be moved and did therefore not fulfill its function.The surgery was finished successfully with another device.It was not necessary to switch the surgical technique or do a second surgery.No further information was provided.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is not confirmed.Functional testing noted that the closed wire loop went through the shaft of the suturelasso¿ sd, 90° curve right without issues.Visual inspection no problem found with the suture lasso 90° curve right returned.No problem found.

• Brand Name: 90 DEG CURVE RIGHT
• 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: 18226514
• Report Number: 1220246-2023-08965
• Device Sequence Number: 15020062
• Product Code: LXH
• UDI-Device Identifier: 00888867031548
• UDI-Public: 00888867031548
• 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): 08/27/2024

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: 90 DEG CURVE RIGHT
• Device Catalogue Number: AR-4068-90R
• Device Lot Number: 3030128777
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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