MAUDE Adverse Event Report: ZIMMER INC NEXGEN PATELLA REAMER BLADE; HTO

Catalog Number 00597909538

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As the instrument was not received, a dhr review was performed and identified no deviations or anomalies.The device is used for treatment.A product history search identified no other complaints for this part and lot combination.Insufficient information was provided and a definitive root cause cannot be determined with the information provided.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It is reported that the instrument was warped and unable to perform as intended.

• Brand Name: NEXGEN PATELLA REAMER BLADE
• Type of Device: HTO
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5568499
• MDR Text Key: 42538038
• Report Number: 1822565-2016-01064
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00597909538
• Device Lot Number: 62724987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1