MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PHOENIX TI-DBLE LEAD CORTICAL 5.0X36MM SCREW; ROD, FIXATION

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the sterile package was found not completely sealed.Other outer packaging seemed to be normal.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi # (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the pouch shows that the seal was at one point sealed.The pouch holding the screw is sealed on one end while the other end was open.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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

No further event information available at the time of this report.

• Brand Name: PHOENIX TI-DBLE LEAD CORTICAL 5.0X36MM SCREW
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7848166
• MDR Text Key: 119344413
• Report Number: 0001825034-2018-08681
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK063570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-405036
• Device Lot Number: 580730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 37 YR