• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED PIN DRIVER - DOUBLE TRIGGER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONMED PIN DRIVER - DOUBLE TRIGGER Back to Search Results
Catalog Number PRO6240
Device Problem Temperature Problem (3022)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Type  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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIN DRIVER - DOUBLE TRIGGER
Type of DevicePIN 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 Key6987839
MDR Text Key253244771
Report Number1017294-2017-00114
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPRO6240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-