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.

• 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
• 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: 8067580
• MDR Text Key: 127071746
• Report Number: 0001822565-2018-06354
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2018

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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2018
• 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