MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 12.6CM TAPERED ATTACH, BM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT

Catalog Number B-TURQ-L

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/25/2015

Event Type  Injury  

Event Description

This is report 2 of 2 for the same event.It was reported that during a lumbar discectomy surgical procedure, it was observed that the motor device was overheating when in use with an attachment device.The reporter indicated that the attachment device was also hot due to the motor device.According to the report, the devices got so hot that they burned the surgeon¿s finger.The surgeon was wearing two gloves at the time of the event and had to quickly remove the gloves.The reporter stated that there was no serious injury to the surgeon.The surgeon was reported to be ¿doing fine¿.There were no delays to the planned surgical procedure as identical spare devices were available to complete the surgery successfully.There was patient involvement reported.There were no reports of prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Initial reporter: there was no contact phone number provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12.6CM TAPERED ATTACH, BM
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4610162
• MDR Text Key: 5761684
• Report Number: 1045834-2015-10567
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-TURQ-L
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR DEVICE
• Patient Outcome(s): Required Intervention