MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH; ROD, FIXATION

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint photographs were evaluated and the reported event was not confirmed review of photographs determined that the products are acceptable per both visual aid review of a provided photo of the packaging determined that no failure was found as the product is within specification(s).No further investigation or action is required after review.Review of the device history records and a complaint history review was not performed per device meeting specifications.Review of a provided photo of the packaging determined that no failure was found as the product is within specification.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 is reported that during incoming package inspection the package was found with a crease in the sealing area.There was no adverse events reported as a result of this malfunction as there was no patient involvement.

• Brand Name: TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH
• 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: 7996773
• MDR Text Key: 124744380
• Report Number: 0001822565-2018-05820
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 47249009800
• Device Lot Number: 64053675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/23/2018
• 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