MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOW PROFILE CORTICAL SCREW WASHER; PLATE, FIXATION

Model Number N/A

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Reporter had indicated that product will not be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that foreign substances were inside of the sterile packages.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned products identified that there is debris inside the sterile package.Review of the device history records identified no related deviations or anomalies.These products likely left zimmer biomet control non-conforming.The root cause of the reported issue is attributed to manufacturing deficiency.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: LOW PROFILE CORTICAL SCREW WASHER
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7470278
• MDR Text Key: 106850810
• Report Number: 0001825034-2018-03069
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK101240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 851218000
• Device Lot Number: 377370
• Other Device ID Number: (01)00887868055058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1