FDA Adverse Event Malfunction Summary report: N

12 V BATTERY

MDR report key: 3964780 · Received July 29, 2014

Report

Report Number: 3009450871-2014-10283
Event Type: Malfunction
Date Received: July 29, 2014
Report Date: July 16, 2014
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HWE
PMA / PMN Number: PEXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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.

Additional Manufacturer Narrative · 1

THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE WAS WORN OUT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. 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 BY (B)(6) THAT THE BATTERY DEVICE ¿DOES NOT LOAD¿. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS 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
441579	12 V BATTERY	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT	HWE	DEPUY SYNTHES POWER TOOLS		C120221

Patients

Seq	Age	Sex	Outcome	Treatment
1