MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, CPR MINI SCORPION DX; POLYETHYLENE SYNTHETIC SUTURE

Model Number	IMPLANT SYSTEM, CPR MINI SCORPION DX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that the 2mm by 11mm quickfix screw from an ar-8690ds cpr implant system would not fit into the pin driver.The shaft of the screw appeared to be too wide.After numerous attempts, the surgeon requested another pin driver, but the screw wouldn¿t fit either.A second cpr kit was opened, and the 2.0mm x11mm screw was implanted successfully.This was discovered during a complete plantar plate repair procedure on (b)(6) 2023.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint allegation is not confirmed.Visual inspection identified the tip of the 2.0x11mm (magenta) of the 2.0mm quickfix screw had broken off.The edges of the threads were warped, and the pin (diameter) of the screw had bent.Dimensional evaluation at ø.080±.003 is in tolerance at.081 per drawing c13053.Functional testing performed noted that the pin of the screw did work as required.No problem found.

• Brand Name: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19563471
• Report Number: 1220246-2024-06027
• Device Sequence Number: 18020722
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Device Catalogue Number: AR-8690DS
• Device Lot Number: 15056755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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