MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIBULA COMP LOCK PLATE 6H STE; PLATE, FIXATION

Catalog Number 856204006

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that there was a hole in the sterile packaging.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned product found the sterile packaging has been damaged.Complaint is confirmed.Sterility has been compromised.Device history record was reviewed and no discrepancies were found.These products were likely conforming when they left zimmer biomet control.The root cause of the reported event can be attributed to transit damage.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: FIBULA COMP LOCK PLATE 6H STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11059643
• MDR Text Key: 223719498
• Report Number: 0001825034-2020-04420
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 856204006
• Device Lot Number: 300030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1