FDA Adverse Event Malfunction Summary report: N

BATTERY OSCILLATOR II FOR BPL II

MDR report key: 4760579 · Received May 8, 2015

Report

Report Number: 3009450871-2015-11411
Event Type: Malfunction
Date Received: May 8, 2015
Date of Event: August 1, 2014
Report Date: August 1, 2014
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: GEY
PMA / PMN Number: PEXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PREVIOUS REPORT STATED THE DEVICE WAS RETURNED AND EVALUATED. HOWEVER, THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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

ADDITIONAL NARRATIVE: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BATTERY OSCILLATOR DEVICE WAS HAVING ISSUES LOCKING THE BLADE DEVICE DOWN. THE EVENT DID NOT OCCUR DURING SURGERY. IT WAS REPORTED THAT THIS DEVICE IS USED IN LAB SETTINGS ONLY AND NOT USED IN CLINICAL SETTINGS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE 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
303871	BATTERY OSCILLATOR II FOR BPL II	MOTOR, SURGICAL INSTRUMENT, AC-POWERED	GEY	DEPUY SYNTHES POWER TOOLS		100103

Patients

Seq	Age	Sex	Outcome	Treatment
1