MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE DISPOSABLE BLADE ASSEMBLY; CARPAL TUNNEL RELEASE BLADE ASSEMBLY

Model Number 81010-6

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  malfunction  

Event Description

Surgeon inserted carpal tunnel disposable blade into the patient and deployed the blade.Two (2) metal slivers came out with the blade.The surgeon had to irrigate the area to remove the slivers.Per (b)(6), or supervisor at the facility, the patient was not injured and no medical intervention was required.

• Brand Name: MICROAIRE DISPOSABLE BLADE ASSEMBLY
• Type of Device: CARPAL TUNNEL RELEASE BLADE ASSEMBLY
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer Contact: donna elliott ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758370
• MDR Report Key: 5331134
• MDR Text Key: 35034314
• Report Number: 2020601-2015-00103
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 81010-6
• Device Catalogue Number: 81010-6
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1