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

Model Number 00505800100

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2022

Event Type  malfunction  

Event 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
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED ACCESSORY/ATTACHMENT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 13666307
• MDR Text Key: 286583370
• Report Number: 13666307
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 20845854018924
• UDI-Public: (01)20845854018924
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00505800100
• Device Catalogue Number: 00505800100
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Weight: 61 KG