MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM - TEAR DROP GUIDE WIRE; ROD, FIXATION

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.Expected, not yet received.

Event Description

It was reported during incoming inspection at the warehouse, that it was discovered there was a crease in the sealing area.There was no patient involvement.

Event Description

No additional information received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was not confirmed.Evaluation of the returned products found the seal to be within specifications.Since the seal was acceptable and there would be no risk to the sterility of the device, re-evaluation of this product to no longer be reportable for this event; the event is being reported on 0001822565-2018-06344.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER NATURAL NAIL SYSTEM - TEAR DROP GUIDE WIRE
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8067585
• MDR Text Key: 127069580
• Report Number: 0001822565-2018-06355
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K101622
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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: N/A
• Device Catalogue Number: 47249009700
• Device Lot Number: 64048689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1