MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXACT ALLIANCE TAPER REAMER 15MM; FLEXIBLE INTRAMEDULLARY REAMER

Model Number N/A

Device Problems Flaked (1246); Peeled/Delaminated (1454)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It was reported that the titanium nitride coating on some reamers have been chipping.No additional information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned device confirms the reported event.Visual inspection verified the gold nitride coating discolored and showed wear on the reamer flutes.The device has signs of wear indicating the field use of the device in its potential age of approximately 9 years.Review of the device history records identified no deviations or anomalies that would have contributed to the reported event.The root cause is instrument wear out due to extended use.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: EXACT ALLIANCE TAPER REAMER 15MM
• Type of Device: FLEXIBLE INTRAMEDULLARY REAMER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6061919
• MDR Text Key: 58850609
• Report Number: 0001825034-2016-04302
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: X31-400035
• Device Lot Number: 340704
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1