MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 10 X 180MM; PROSTHESIS, KNEE

Catalog Number 14-440118

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has not been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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.

Event Description

It was reported that when the package was opened, it was noticed that the inner sterile packaging had a foreign material inside.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the returned product determined that the packaging is unsealed and a bug like material was found in the packaging.Dhr was reviewed and no discrepancies were found.As the product was returned opened and unsealed, at this time as the bug could have been introduced after the product was opened.A definitive root cause cannot be determined.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.

Event Description

It was reported that when the package was opened, it was noticed that the inner sterile packaging had a foreign material inside.No adverse events have been reported as a result of the malfunction.

• Brand Name: ANKLE LOCKING NAIL 10 X 180MM
• Type of Device: PROSTHESIS, KNEE
• 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: 7628571
• MDR Text Key: 111985060
• Report Number: 0001825034-2018-04208
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK091976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-440118
• Device Lot Number: 535740
• Other Device ID Number: (01)00887868093548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1