FDA Adverse Event Injury Summary report: N

ELECTRONIC POWER SUPPLY W/O CORD

MDR report key: 6442179 · Received March 29, 2017

Report

Report Number: 0008031000-2017-00008
Event Type: Injury
Date Received: March 29, 2017
Date of Event: December 19, 2016
Report Date: August 10, 2017
Manufacturer: ZIMMER SURGICAL SA
Product Code: HAB
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ELEC PWR SUPPLY W/O CORD, SERIAL NUMBER (B)(4) WAS RETURNED FOR COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. UPON RECEIPT, IT WAS CONFIRMED THAT A MODULE WAS DEFECTIVE. THE EVENT REPORTED BY THE CUSTOMER, "IT STOP", WAS CONFIRMED BECAUSE THE DEVICE WAS NOT FUNCTIONAL DUE TO THE DEFECTIVE MODULE. THE DEVICE WAS NOT REPAIRED AND IT WILL BE RECYCLED IN ZIMMER PREMISES. THE DEVICE WAS REPLACED BY A NEW ONE, SERIAL NUMBER (B)(4). THE CUSTOMER DECLARED THAT THE CAUSE OF THE DELAY IN SURGERY WAS DUE TO ANOTHER DEVICE: THE ELEC PWR SUPPLY W/O CORD, SERIAL NUMBER (B)(4). THE FOLLOW-UP REPORT MDR95978 RELATED TO THIS PRODUCT WAS SUBMITTED ON 03-AUG-2017.

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE DATE OF THIS REPORT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ELECTRONIC POWER SUPPLY, SERIAL NUMBER (B)(4) STOPPED. THE SURGERY DELAY WAS 2 HOURS. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO ADDITIONAL HARM OR INJURY TO PATIENT/OPERATOR REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
225885	ELECTRONIC POWER SUPPLY W/O CORD	ELECTRONIC POWER SUPPLY W/O CORD	HAB	ZIMMER SURGICAL SA	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR		Other