MAUDE Adverse Event Report: CONMED PIN DRIVER - DOUBLE TRIGGER

Catalog Number PRO6240

Device Problem Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed after the device evaluation and complaint investigation are completed.

Event Description

The user facility reported a patient suffered a secondary burn from heat generated by rotational force on a pro6240 during an orif clavicle procedure.This burn was treated medically.To date, no additional information has been provided.This report is raised on the basis of a reported patient injury.

Manufacturer Narrative

The reported handpiece was returned to conmed for evaluation.Functional testing was performed and the device issue was verified.Within 10-seconds, the device reached over 200f at the tip of the nose.The thrust bearing was broken and the bearing balls were missing.When the lever is pulled to make the unit run, friction was generated due to the rotation between the nose and sleeve which resulted in an excessive amount of heat.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.This device, manufactured in 2014, has no record of service.Per the manufacturer's instructions for use, this device has a recommended service interval of 12 months.A two-year review of historical complaint data revealed no prior similar issues have been reported.In that same timeframe, (b)(4) devices have been manufactured.The instructions for use advise the user of the following.Continually inspect the device for overheating during use.Overheating may cause damage to the bur, bit or blade.This may cause thermal necrosis.Overheating may cause burn injury to the patient or medical personnel.Recommended service schedule for this device is every 12 months.This incident type will continue to be monitored through the complaint system to assure patient and user safety.

• Brand Name: PIN DRIVER - DOUBLE TRIGGER
• Type of Device: PIN DRIVER - DOUBLE TRIGGER
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 6987839
• MDR Text Key: 90579270
• Report Number: 1017294-2017-00114
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRO6240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1