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

Catalog Number 829029170

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).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 was reported that there was debris in the sterile packaging.This was discovered at incoming inspection.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d10, g4, g7, h2, h3, h6, h10.The complaint sample was evaluated and the reported even was confirmed.The returned product packaging showed foreign matter within the sterile barrier.The debris was evaluated and found to be non-conforming.The device history records were reviewed and no discrepancies were identified.The device was likely non-conforming when it left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.No further actions have been initiated to further address the reported issue.This complaint was determined not to be a new confirmed quality or manufacturing issue.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

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

• Brand Name: 2.5X140MM DRILL STE
• Type of Device: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10178817
• MDR Text Key: 195941022
• Report Number: 0001825034-2020-02439
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• 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: 324560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1