MAUDE Adverse Event Report: BIOMET REAMER

Catalog Number 31-476798

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 07/27/2017

Event Type  Injury  

Event Description

Cpd manager was informed the biomet reamer had visible bioburden despite multiple cleanings and sterilizations.In the design it has a piece that can harbor bioburden despite appropriate cleaning.Product removed from service.There are eight devices total.

• Brand Name: REAMER
• Type of Device: REAMER
• Manufacturer (Section D): BIOMET
• MDR Report Key: 6753696
• MDR Text Key: 81501715
• Report Number: MW5071291
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2017
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 31-476798
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1