MAUDE Adverse Event Report: BIOMIMETIC THERAPEUTICS, LLC AUGMENT® INJECTABLE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	K30003010
Medical Device Problem Code	Clumping in Device or Device Ingredient (1095)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available.
Event or Problem Description
It was reported that the surgeon asked for a 3cc kit.One was brought into the room.The premix procedure was followed.The material did not reconstitute correctly, it remained almost like a powder after the fluid was mixed.Surgeon was unable to use the graft as it would not hold in place in the joint.Another 3cc kit was not in house so two 1.5cc grafts were used and reconstituted.Both of them reconstituted just fine and were able to utilize them.The surgeon felt it was a defect in perhaps the fluid or something that caused the first failure to reconstitute and did not want the patient charged for the 3cc graft.2x 1.5cc augment injectable were used.The impact to the patient was added time under anesthesia and their expense.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Instructions require the customer to introduce the pdgf liquid into the shredded matrix solids.The material should then "sit/rest" for a specified amount of time to allow the solids to be fully wetted/hydrated before proceeding to further mixing steps.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material or manufacturing related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the surgeon asked for a 3cc kit.One was brought into the room.The premix procedure was followed.The material did not reconstitute correctly, it remained almost like a powder after the fluid was mixed.Surgeon was unable to use the graft as it would not hold in place in the joint.Another 3cc kit was not in house so two 1.5cc grafts were used and reconstituted.Both of them reconstituted just fine and were able to utilize them.The surgeon felt it was a defect in perhaps the fluid or something that caused the first failure to reconstitute and did not want the patient charged for the 3cc graft.2x 1.5cc augment injectable were used.The impact to the patient was added time under anesthesia and their expense.

• Brand Name: AUGMENT® INJECTABLE
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): BIOMIMETIC THERAPEUTICS, LLC; 389 nichol mill lane; franklin TN 37067
• Manufacturer (Section G): BIOMIMETIC THERAPEUTICS, LLC; 389 nichol mill lane; franklin TN 37067
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12418410
• Report Number: 3003897776-2021-00004
• Device Sequence Number: 3476946
• Product Code: NOX
• UDI-Device Identifier: 10859477002140
• UDI-Public: 10859477002140
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 02/28/2023
• Device Model Number: K30003010
• Device Catalogue Number: K30003010
• Device Lot Number: 1709000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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