MAUDE Adverse Event Report: ARTHREX, INC. GRAFTPRO, GRAFT PREP BOARD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GRAFTPRO, GRAFT PREP BOARD
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/12/2024, it was reported by a sales representative via (b)(4) that an ar-2950d graftpro¿ graft prep boards prongs grew to be sticky and started leaving a white residue when you moved the prong across the board.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed per pictures attached and showed the signs of wear and tear of the device.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 of this failure is attributed to wear and tear damage incurred over repeated usage in the field.Manufactured date 2016.

• Brand Name: GRAFTPRO, GRAFT PREP BOARD
• 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: 19904952
• Report Number: 1220246-2024-07015
• Device Sequence Number: 7065087
• Product Code: LXH
• UDI-Device Identifier: 00888867221505
• UDI-Public: 00888867221505
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: GRAFTPRO, GRAFT PREP BOARD
• Device Catalogue Number: AR-2950D
• Device Lot Number: 43211608
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 06/08/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown