MAUDE Adverse Event Report: BRASSELER USA, MEDICAL L.L.C. ZIMMER MILLBRASSERLER USA MEDICAL, LLC MILLING HANDPIECE

Model Number ZIMMER MILL 00-5927-040-00 REV E

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2015

Event Type  malfunction  

Manufacturer Narrative

The handpiece was returned with a bur/cutter seized in the collet.Upon removal of the bur/cutter it was identified that galling was present in the collet nose housing and collet spindle.The information provided with the complaint indicates that the bur was not properly locked in the collet prior to operating the handpiece.If the bur is not properly locked in place this allows the bur to migrate during use, causing additional galling between the bur/cutter and collet then during typical use, and is likely to result in a seizure of the bur/cutter in the collet and other failures.Surgeons using this system should be familiar w/the proper use of this handpiece as instructed in the zimmer inc.Pfj system surgical technique; section 6.2, to "insert bur fully into collet until flush" and illustrated in fig.32, showing the position of a bur/cutter flush w/the collet and fully seated in the collet.The complaint description also indicates that the user experienced difficulty achieving full insertion of the bur/cutter and proper lock down inside the collet due to metal to metal galling between the bur/cutter, the collet nose housing, and the collet spindle during a prior operation.Excessive bending, lateral forces, exceeding the recommended psi setting , and other aggressive use may contribute to the galling condition.

Event Description

The customer stated the following: anterior cut guide was used correctly.Cut was made without incident.We sized the femoral trochlea.Size 3 was adequate.Milling guide was secured correctly.The burr was then placed into the milling hand piece.Upon inserting the burr into the handpiece, the burr itself would not slide down into the handpiece all the way.We double checked to be sure the handpiece was in the open position and the hand piece was then turned to locked position.At this point we went to mill the femur and once in contact with the bone, the burr slid out of position in the handpiece.We then switched to the other handpiece that comes in the set.Opened a new burr as well.And we encountered the same results.The burr continued to slide in the handpiece as the surgeon milled in the appropriate channels.We were able to complete the case and implant a zimmer pfr size 3.However, dr.Berend, was not happy with the product instrumentation.He felt his patient was in danger due to the equipment not working properly and malfunctioning.

• Brand Name: ZIMMER MILLBRASSERLER USA MEDICAL, LLC MILLING HANDPIECE
• Manufacturer (Section D): BRASSELER USA, MEDICAL L.L.C.; 4837 mcgrath st., suite j; ventura CA 93003
• Manufacturer (Section G): BRASSELER USA, MEDICAL L.L.C.; 4837 mcgrath st., suite j; ventura CA 93003
• Manufacturer Contact: kenneth jones ; 4837 mcgrath st., suite j; ventura, CA 93003 ; 9129217501
• MDR Report Key: 5409807
• MDR Text Key: 37531785
• Report Number: 2025102-2016-00001
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZIMMER MILL 00-5927-040-00 REV E
• Device Catalogue Number: 00-5927-040-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2009
• 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
• Patient Age: 59 YR