MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5X140MM DRILL STE; TRAUMA, INSTRUMENT

Catalog Number 829029170

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Information (3190)

Event Date 11/19/2018

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.Product not returned.

Event Description

It was reported that incoming inspection found a protrusion on the sterile package.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Report source : the event occurred in japan.Reported event was unable to be confirmed due to limited information received from the customer.Review of the provided picture identified that there is an indentation on the packaging, however, it cannot be identified if it is on the sterile packaging and whether sterility is compromised.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: 2.5X140MM DRILL STE
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8145891
• MDR Text Key: 129753834
• Report Number: 0001825034-2018-11061
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 829029170
• Device Lot Number: 241780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1