MAUDE Adverse Event Report: CONMED CORPORATION SURGAIRTOME TWO; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT

Model Number	00505800100
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A burr snapped in half at the sterile field during surgery due to a broken locking mechanism on a surgairtome.

• Brand Name: SURGAIRTOME TWO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 13666307
• Report Number: 13666307
• Device Sequence Number: 14617337
• Product Code: HSZ
• UDI-Device Identifier: 20845854018924
• UDI-Public: (01)20845854018924
• 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): 02/22/2022
• Report Date (Section F): 02/22/2022

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: 00505800100
• Device Catalogue Number: 00505800100
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 61 KG
• Date Report Sent to FDA: 02/22/2022