FDA Adverse Event Malfunction Summary report: N

SMALL BATTERY DRIVE

MDR report key: 3884915 · Received June 19, 2014

Report

Report Number: 1045834-2014-12287
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: June 4, 2014
Report Date: June 4, 2014
Manufacturer: SYNTHES OBERDORF
Product Code: HWE
PMA / PMN Number: PEXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER LOCATION WAS DOCUMENTED AS (B)(4) IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO (B)(4). CONTACT OFFICE NAME/ADDRESS HAVE BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTED MANUFACTURING FACILITY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative · 1

THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO INTERNAL MOTOR OR (ECU) ELECTRONIC CONTROL UNIT FAILURE DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO SURGERY, DURING PRE-TESTING, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE DID NOT WORK. THERE WERE NO DELAYS TO THE SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE IDENTICAL DEVICE WAS AVAILABLE. 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
360064	SMALL BATTERY DRIVE	INSTR.SURGICAL. ORTHOPEDIC.AC-POWERED MOTOR/ACCESS & ATTACH	HWE	SYNTHES OBERDORF		001056

Patients

Seq	Age	Sex	Outcome	Treatment
1