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

Model Number K30003010

Device Problem Clumping in Device or Device Ingredient (1095)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 272962693
• Report Number: 3003897776-2021-00004
• Device Sequence Number: 1
• Product Code: NOX
• UDI-Device Identifier: 10859477002140
• UDI-Public: 10859477002140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1