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

Catalog Number 00597909532

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/11/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information was received from a foreign source who is not required to complete form 3500a.The device was received for evaluation.Visual and photo inspection revealed minimal scuffing and gouging on the outer diameter of the reamer blade where it comes into contact with the guide.Functional testing revealed that the reamer blade was accepted by the applicable gages.The device was used for treatment.The surgical technique for preparation of the patella using the zimmer patella reamer indicates that proper use is to insert the reamer into the insetting guide and then "bring the reamer up to full speed and advance it slowly until the prominent high points are reamed off".The reporter indicated that proper technique was followed and the blade was inserted prior to the reamer being started.The reported condition cannot be confirmed.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 32mm patella reamer blade got stuck in the patella reaming guide during surgery.

• 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: 5572274
• MDR Text Key: 42984101
• Report Number: 1822565-2016-01144
• 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: Other
• Type of Report: Initial
• Report Date: 12/11/2013

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: 00597909532
• Device Lot Number: 62429358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• 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: 74 YR