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

Catalog Number 89-0000-420-00

Device Problems Failure to Power Up (1476); Electrical Power Problem (2925)

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 89-0000-420-00 serial number (b)(4) does not turn on.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

Several attempts were made in effort to retrieve the elec power supply w cord, serial number (b)(4), without success.The device was not returned for complaint investigation.Therefore, it could not be visually inspected in an effort to confirm the defect.A follow-up medwatch will be submitted if the product is returned or if additional information is received.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 pré 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: 6441966
• MDR Text Key: 71100213
• Report Number: 0008031000-2017-00006
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-0000-420-00
• Device Lot Number: 33728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2008
• 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