FDA Adverse Event Malfunction Summary report: N

SMALL BATTERY DRIVE

MDR report key: 4862067 · Received June 23, 2015

Report

Report Number: 3009450871-2015-12203
Event Type: Malfunction
Date Received: June 23, 2015
Date of Event: May 27, 2015
Report Date: May 27, 2015
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HWE
PMA / PMN Number: PEXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: SERVICE AND TESTING PERSONNEL

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED FOR SERVICE, HOWEVER DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. IT WAS FURTHER OBSERVED THAT THE WIRES ON THE ELECTRONIC CONTROL UNIT WERE DAMAGED AND INTERNAL COMPONENTS WERE WORN. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR ON COMPONENTS FROM REPEATED STERILIZATION AND NORMAL USE OVER TIME. 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

IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE FAILED POWER CHECK WITH TEST BENCH AS THE TRIGGER ON THE DEVICE INTERMITTENTLY JAMMED. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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
406134	SMALL BATTERY DRIVE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT	HWE	DEPUY SYNTHES POWER TOOLS		3772

Patients

Seq	Age	Sex	Outcome	Treatment
1