FDA Adverse Event Malfunction Summary report: N

10.5CM ANGLE ATTACHMENT

MDR report key: 3923658 · Received July 9, 2014

Report

Report Number: 1045834-2014-12385
Event Type: Malfunction
Date Received: July 9, 2014
Date of Event: June 24, 2014
Report Date: June 24, 2014
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HBC
PMA / PMN Number: PK011444
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE MET ALL MANUFACTURE'S SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. .

Description of Event or Problem · 1

THIS IS REPORT 3 OF 4 OF THE SAME EVENT, IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL SURGERY, IT WAS OBSERVED THAT A MOTOR DEVICE AND THREE ATTACHMENT DEVICES WERE HEATING UP. THE REPORTER WAS UNABLE TO CLARIFY WHICH DEVICE WAS HEATING UP. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS IDENTICAL SPARE DEVICES WERE AVAILABLE FOR USE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SPARE DEVICES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
400578	10.5CM ANGLE ATTACHMENT	MOTOR, DRILL, ELECTRIC - ATTACHMENT	HBC	DEPUY SYNTHES POWER TOOLS		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				MOTOR DEVICE