MAUDE Adverse Event Report: PMT CORP. PMT TORQUE DRIVER

Model Number 1201-8

Device Problem Failure to Recalibrate (1517)

Patient Problem Infiltration into Tissue (1931)

Event Type  Injury  

Event Description

Info provided from the distributor ((b)(6)): during the application of a halo-fixateur, one pin broke through the calotte.The pt did not sustain any further injuries and is free of complaints.This occured at (b)(6).

Manufacturer Narrative

The torque driver has not been returned to pmt for inspection/investigation per request of pmt to our (b)(6) distributor.No other procedures used on the pt were returned to pmt for inspection/investigation.The distributor has not provided any additional info per pmt corporation's requests the past two weeks.The pmt torque driver is supposed to be calibrated on an annual basis per the labeling on the device that states "calibration due date (b)(4)".This device has been past the calibration due date for over 7 years.Pmt is attempting to get back the torque driver for evaluation but we assume it was user error based upon the fact that the skull pin penetrated the thickest portion of the skull and the skull pins are designed to penetrate the skull only 2mm and the portion of the skull, the calotte, is several factors thicker.It is assumed that the torque driver was set at a higher torque setting than is known by learned intermediary for such a procedure.

• Brand Name: PMT TORQUE DRIVER
• Type of Device: TORQUE DRIVER
• Manufacturer (Section D): PMT CORP.; 1500 park rd.; chanhassen MN 55317
• Manufacturer Contact: al iversen ; 1500 park rd.; chanhassen, MN 55317 ; 9524700866
• MDR Report Key: 3961815
• MDR Text Key: 4609511
• Report Number: 2182979-2014-00002
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2007
• Device Model Number: 1201-8
• Device Catalogue Number: 1201-8
• Device Lot Number: 030306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention