MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD TIBIAL TRIAL HANDLE/ALIGNMENT TOWER; INSTRUMENT, KNEES

Model Number N/A

Device Problems Corroded (1131); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the screw on the tibial alignment tower had evidence of corrosion and had subsequently broken, rendering the instrument unusable.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the short pin is fractured with part of the pin still inside the handle.The short pin shows discoloration consistent with corrosion near the fracture.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: VANGUARD TIBIAL TRIAL HANDLE/ALIGNMENT TOWER
• Type of Device: INSTRUMENT, KNEES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8864834
• MDR Text Key: 202542926
• Report Number: 0001825034-2019-03448
• Device Sequence Number: 1
• Product Code: MDM
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-486130
• Device Lot Number: 091490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1