MAUDE Adverse Event Report: 14X26 MAX CUTTER AND 14X26 MACI KIT/15MM X 4CM CANNULA ASSEMBLY

Lot Number	75DD7498
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Case reference number (b)(4) is a spontaneous report received from a healthcare professional, on 20-jan-2025 regarding the 14 mm x 26 mm max arthroscopic cutter and 14 mm x 26 mm maci cutter kit, along with the 15mm x 4cm cannula assembly.On (b)(6) 2025, an arthroscopic maci implantation was performed.The patient was prepped with arthroscopic kitted device (14 mm x 26 mm max arthroscopic cutter and 14 mm x 26 mm maci cutter kit, lot number: 75hd2871, expiration date: 21-jan-2025).During the surgery, the instrument was stuck and part of the cutting mechanism, at the end of the arthroscopic cutter, broke off (pt: device breakage).It was reported that the surgeon was able to retrieve it through the cannula (15mm x 4cm cannula assembly; lot number: 75dd7498, expiration date: 21-jan-2025).The cannula dam became leaky during the procedure and afterwards, the water was flowing out of the dam throughout the case (pt: device leakage).A new cutter was opened, but eventually, the case was converted to an open approach (arthrotomy) and completed successfully.No adverse event was reported.Additional information was received on 30-jan-2025 and processed with the initial.No further information was provided.Company comment: vericel has assessed the event of device leakage as non-serious, possibly related and expected per convention.The event of device breakage is assessed as serious (due to medical significance), possibly related and expected per convention the case qualifies as a 30-day mdr.
Event or Problem Description
The end of the arthroscopic cutter broke off [device breakage], water was flowing out of the dam [device leakage].

• Brand Name: 14X26 MAX CUTTER AND 14X26 MACI KIT/15MM X 4CM CANNULA ASSEMBLY
• Common Device Name: 14X26 MAX CUTTER AND 14X26 MACI KIT/15MM X 4CM CANNULA ASSEMBLY

64 sydney st

cambridge, MA 02139

• MDR Report Key: 21408933
• Report Number: 3002836339-2025-00017
• Device Sequence Number: 8235124
• Product Code: NBH
• UDI-Device Identifier: 00860004093022
• UDI-Public: 00860004093022
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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 Expiration Date: 01/21/2025
• Device Lot Number: 75DD7498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 02/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Male