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

Catalog Number 00597909541

Device Problems Mechanical Problem (1384); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 11/11/2014

Event Type  malfunction  

Manufacturer Narrative

It is reported that a nexgen patella reamer blade with pilot hole would not fit the appropriate reamer guide.The part was returned with the complaint for review.Visual examination revealed gouging and scratches on the outer diameter of the reamer where it comes into contact with the guide.The device passed gage testing which verifies the functionality and location of the locking slots on the patella reamer blade.The instrument failed gage testing which verifies the maximum permissible outside diameter.The locking tabs were noted to be bent outward.The device is used for treatment.A product history search found no other complaints against this part and lot combination.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 was reported that the patella reaming blade malfunctioned with the patellar reaming system.The blade was not able to be introduced to the patellar bone.

• Brand Name: NEXGEN PATELLA REAMER BLADE
• Type of Device: HTO
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5568391
• MDR Text Key: 42376186
• Report Number: 1822565-2016-01088
• 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: Physician
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00597909541
• Device Lot Number: 62719640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1