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

Model Number	K30003010
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional 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.Packaging discarded.
Event or Problem 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 of 1.5cc to get the 3cc total.This was combined with an additional 3cc kit as the surgeon wanted 6cc in total.

• Brand Name: AUGMENT INJECTABLE
• Common Device Name: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): BIOMIMETIC THERAPEUTICS, LLC; 389 nichol mill lane; franklin TN 37067
• MDR Report Key: 12518282
• Report Number: 3003897776-2021-00007
• Device Sequence Number: 4291033
• Product Code: NOX
• UDI-Device Identifier: 10859477002140
• UDI-Public: 10859477002140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: 06/30/2023
• Device Model Number: K30003010
• Device Catalogue Number: K30003010
• Device Lot Number: 1706343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2335-2021
• Patient Sequence Number: 1