MAUDE Adverse Event Report: ZIMMER, INC. PATELLA REAMER BLADE WITH PILOT HOLE; KNEE INSTRUMENT

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patella reamer blade bound up inside the reamer guide and locked up.Another patella reamer blade was opened and used to complete the surgery.

Manufacturer Narrative

No product was received with complaint for investigation; therefore, the condition of the patella reamer blade with pilot hole is unknown.Without a device for exam, neither visual nor dimensional analysis is possible.The device history records for the product part and lot numbers were reviewed and identified no deviations or anomalies.This device is used for treatment.A complaint history search identified no other complaint for the part/lot combination of the component.It was reported that the proper surgical technique was used.It is considered that the patella reamer guide in which the blade got stuck did not cause the issue because there was no problem using another blade with this guide.A definitive root cause cannot be determined with the information provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.The following information updated: device availability, device evaluated by manufacturer.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.As received the reamer blade exhibits scratches and gouges to the outer diameter.The returned blade passed the functional test for slot location angle and failed the functional test for ring slot position.Dimensional inspection found that the inner and outer diameters were conforming to print specifications.The device history records for the 00-5979-095-46, lot # 63275323 and receiving inspection report for 00-5979-595-46, lot # 80708147 were reviewed and no deviations or anomalies were identified.This device is used for treatment.A complaint history search identified no other complaint for lot #63275323 and 18 additional complaints for part # 00597909546, for the same or similar issue.It was reported that the proper surgical technique was used.It is considered that the patella reamer guide in which the blade got stuck did not cause the problem because there was no problem using another blade with this guide.Although the outer diameter measurements of the returned blade conform to print specifications, the failed functional test for the ring slot position indicates that the circular wall of the blade is deformed.However, it is not possible to find out whether the deformation existed before or after the failed use of the blade.A definitive root cause cannot be determined with the information provided.

• Brand Name: PATELLA REAMER BLADE WITH PILOT HOLE
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5726348
• MDR Text Key: 47490369
• Report Number: 0001822565-2016-02040
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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,Followup,Followup,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• 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: 00597909546
• Device Lot Number: 63275323
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1