MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 09/23/2016

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 universal electric/battery double trigger handpiece lose power during use.Therefore, the surgery was delayed for 40 minutes.The delay correspond to the time necessary to find another handpiece.The surgery was completed with another device.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece serial number (b)(4) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the controller board connector and the battery support were defective.The event reported by the customer was confirmed.As a result the controller board (including the connector) and the batterysupport were replaced.After repair, the product was tested and it was returned to the customer.

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece serial number (b)(4) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the controller board connector and the battery support were defective.The event reported by the customer was confirmed.As a result the controller board (including the connector) and the battery support were replaced.After repair, the product was tested and it was returned to the customer.Additional information was received: a backup device was used to complete the surgery and the reason of the delay was the time needed to prepare it.

• Brand Name: UNIVERSAL ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin pré fleuri 3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: jennifer hutchison ; chemin du pré fleuri, 3; plan-les-ouates, geneva, IN ; 3438801000
• MDR Report Key: 6039269
• MDR Text Key: 57789847
• Report Number: 0008031000-2016-00012
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2017

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 Model Number: N/A
• Device Catalogue Number: 89-8507-400-00
• Device Lot Number: AF55474
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided; 11/28/2016
• Supplement Dates FDA Received: 12/02/2016; 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2011
• 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