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

Catalog Number 00597909535

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information was received from a foreign source who is not required to complete form 3500a.The product was not provided nor was a photo sent in for evaluation; therefore, the condition of the device unknown.The device history record review found this lot to be conforming; indicating the device was manufactured, inspected, and packaged to specifications.The device is used for treatment.A product history search found no other complaints against the related part and lot combination.With the information provided and without the actual device to examine, a definitive root cause cannot be determined.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported during surgery that the 35mm patella reaming blade kept getting stuck and would not ream the patella.Multiple attempts were made.

• 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: 5570788
• MDR Text Key: 43014903
• Report Number: 1822565-2016-01224
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 00597909535
• Device Lot Number: 62404460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR