MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE; BURR, ORTHOPEDIC

Model Number ZB-214

Device Problem Break (1069)

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

Event Date 10/16/2019

Event Type  malfunction  

Event Description

Burr broke through normal use during a right hip implant revision procedure.

• Brand Name: MICROAIRE
• Type of Device: BURR, ORTHOPEDIC
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS LLC; 3590 grand forks blvd; charlottesville VA 22911
• MDR Report Key: 9354386
• MDR Text Key: 167389401
• Report Number: 9354386
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZB-214
• Device Lot Number: 1218334412
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Weight: 86