MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET BIOLOGICS SPRAY APPLICATOR KIT; SYRINGE, IRRIGATING

Model Number N/A

Device Problems Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection identified a hair without disturbing sealed pouch.Noted that hair was not inside kit tray as originally thought; hair was located between kit tray and tyvek pouch.Review of complaint history found no additional related issues for this item.Device history record (dhr) was reviewed and no discrepancies were found.Root cause attributed to the bouffant provided to cleanroom employees did not contain all hair, which allowed one to escape and get packaged in the product.Further review was performed and found approximately (b)(4) units out of (b)(4) units have been consumed without additional complaint; therefore, this is considered an isolated incident.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

Event Description

It was reported that there was a hair in the sterile packaging while opening for the total hip procedure on (b)(6) 2015.The tech noticed it before it contaminated the sterile field.The patient was not in the room.No further information has been provided.

• Brand Name: BIOMET BIOLOGICS SPRAY APPLICATOR KIT
• Type of Device: SYRINGE, IRRIGATING
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6910106
• MDR Text Key: 88155875
• Report Number: 0001825034-2017-07791
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK940371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 800-0250
• Device Lot Number: 132260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1