MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH; ROD, FIXATION

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported event was considered to be confirmed as visual evaluation of the four returned products confirmed the presence of crease and/or fold in the seal of the pouches.Device history record was reviewed and no discrepancies were found.Root cause was determined to be a manufacturing issue as the likely condition of the parts when they left zimmer biomet control is considered non-conforming based on the evaluation of the returned product.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03314, 0001822565-2018-03316, 0001822565-2019-00789, 0001822565-2019-00793.

Event Description

It was reported that there was a crease in the sealing area of the package.

• Brand Name: TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 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: 8361589
• MDR Text Key: 136860955
• Report Number: 0001822565-2019-00789
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 02/19/2019

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009700
• Device Lot Number: 63983829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1