FDA Adverse Event Malfunction Summary report: N

5.0CM SHORT ATTACHMENT

MDR report key: 3833699 · Received May 27, 2014

Report

Report Number: 1045834-2014-12080
Event Type: Malfunction
Date Received: May 27, 2014
Date of Event: May 9, 2014
Report Date: May 9, 2014
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HBC
PMA / PMN Number: PK011444
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. (B)(4) EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE MET ALL MANUFACTURE SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE HAD AN UNSPECIFIED MALFUNCTION. ACCORDING TO THE REPORTER, THE ATTACHMENT DEVICE WAS ¿HARD TO PUT BURRS IN AND/OR HEATING UP¿. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
310184	5.0CM SHORT ATTACHMENT	MOTOR, DRILL, ELECTRIC - ATTACHMENT	HBC	DEPUY SYNTHES POWER TOOLS		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				CUTTER DEVICE