MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC HALL SURGAIRTOME; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 5058-01

Device Problem Defective Device (2588)

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

Event Date 08/29/2018

Event Type  malfunction  

Event Description

Surgitome required for right first metacarpophalangeal joint (mpj) fusion did not function.

• Brand Name: HALL SURGAIRTOME
• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 7854712
• MDR Text Key: 119497105
• Report Number: 7854712
• Device Sequence Number: 1
• Product Code: GET
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5058-01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20805 DA