MAUDE Adverse Event Report: ZIMMER SURGICAL SA ELECTRONIC POWER SUPPLY W/O CORD

Catalog Number 89-0000-420-10

Device Problem Electronic Property Issue (2928)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: ELECTRONIC POWER SUPPLY W/O CORD
• Type of Device: ELECTRONIC POWER SUPPLY W/O CORD
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6442179
• MDR Text Key: 71161450
• Report Number: 0008031000-2017-00008
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-0000-420-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 75