MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE®; PIN, FIXATION, SMOOTH

Model Number	1600-645
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure surgeon was drilling with a 0.045" k-wire into the patient's right index finger.The k-wire broke into two pieces.One piece remained in patient and removed by surgeon.Both pieces sequestered.X-ray of right hand performed per hospital policy.Results called to surgeon.Procedure completed.

• Brand Name: MICROAIRE®
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS LLC; 3590 grand forks blvd; charlottesville VA 22911
• MDR Report Key: 9166181
• Report Number: 9166181
• Device Sequence Number: 2774385
• Product Code: HTY
• UDI-Device Identifier: 00847399001429
• UDI-Public: (01)00847399001429
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/18/2019
• Report Date (Section F): 09/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1600-645
• Device Lot Number: 0719341706
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 89
• Date Report Sent to FDA: 09/18/2019