MAUDE Adverse Event Report: INTEGRA - ACELL(COLUMBIA) MICROMATRIX, 500 MG; WOUND PARTICULATE DEVICES

Catalog Number	MM0500
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported "plastic" substance was found when a micromatrix vial was emptied into a sterile field.Product was stored in a rfid cabinet that has internal temperature monitoring.Device was within range during storage in the facility.No tools were in contact with the vial.No patient contact/injury reported and the event did not led to surgical delay.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The micromatrix (id (b)(6)) was not returned for evaluation, but a photo was provided, however, it is unclear where the black plastic substance originated from.Device history record (dhr) - the attached lot release testing batch record for lot no 040297 demonstrate that no anomalies or nonconformances occurred during the manufacture or packaging of the device.Root cause analysis - since no device return is available, the root cause is indeterminate.Potential root causes for the plastic substance are that it was already present in the tray shown in the images, that it was introduced during the opening of the vial or introduced during the micromatrix manufacturing processes.

• Brand Name: MICROMATRIX, 500 MG
• Common Device Name: WOUND PARTICULATE DEVICES
• Manufacturer (Section D): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; 6640 eli whitney drive; columbia MD 21046
• Manufacturer (Section G): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; columbia MD 21046
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20368845
• Report Number: 3005920706-2024-00008
• Device Sequence Number: 11698786
• Product Code: KGN
• UDI-Device Identifier: 00386190001189
• UDI-Public: 00386190001189
• Combination Product (Y/N): N
• PMA/510(K) Number: K172399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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 Catalogue Number: MM0500
• Device Lot Number: 040297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown