MAUDE Adverse Event Report: BIOMIMETIC THERAPEUTICS, LLC AUGMENT INJECTABLE; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Model Number K30003010

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event could be confirmed, since inspection of other lots on the shelf were found with the same issue.Based on investigation, the root cause was attributed to a co-mingling related issue.The failure was caused by two partial vial lot boxes (1.5ml and 3.0ml) were consolidated into one box.A non-conformance was opened in the legacy wright nce system and a field action assessment was performed.

Event Description

It was reported that the kit had 1.5cc rhpdgf vial instead of the 3cc rhpdgf vial.The kit was mixed and combined with a second unit.No impact to patient, just less product used than planned.No delay.

• Brand Name: AUGMENT INJECTABLE
• Type of Device: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• 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: 12516746
• MDR Text Key: 272910772
• Report Number: 3003897776-2021-00005
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: K30003010
• Device Catalogue Number: K30003010
• Device Lot Number: 1706343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2335-2021
• Patient Sequence Number: 1