MAUDE Adverse Event Report: ARTHREX, INC. SCORPION SUTURE PASSER WITH FLUSHPORT; ARTHROSCOPIC ACCESSORIES

Model Number	SCORPION SUTURE PASSER WITH FLUSHPORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that the device is broken.Nothing broke off.The reported event was confirmed as the evaluation revealed that the jaw hook is bent out.This is typically caused by applying excessive force while grasping and manipulating suture.Further the device shows signs of metal surface oxidation.
Event or Problem Description
It was reported that the device is broken.There was no harm for patient, operator or third party reported.This was noticed after the surgery.Update nen (b)(6) 2022: nothing broke off.

• Brand Name: SCORPION SUTURE PASSER WITH FLUSHPORT
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 19309721
• Report Number: 1220246-2024-03229
• Device Sequence Number: 12513568
• Product Code: LXH
• UDI-Device Identifier: 00888867293373
• UDI-Public: 00888867293373
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: SCORPION SUTURE PASSER WITH FLUSHPORT
• Device Catalogue Number: AR-13990F
• Device Lot Number: 13721873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown