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

Catalog Number 89-8507-400-00

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 02/23/2017

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 modular electric/battery double trigger handpiece stopped and doesn't function anymore. The surgery delay was between 31 and 60 minutes. 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 motor was seized. Besides, the trigger board connector and the trigger/controller boards wire were defective. The event reported by the customer was confirmed. As a result the motor, the trigger board (including the connector) and the trigger/controller boards wire were replaced. After repair, the product was tested and it was returned to the customer. Another follow-up medwatch will be submitted if new information is available.

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 motor was seized. Besides, the trigger board connector and the trigger/controller boards wire were defective. The event reported by the customer was confirmed. As a result the motor, the trigger board (including the connector) and the trigger/controller boards wire were replaced. After repair, the product was tested and it was returned to the customer. Additional information was received: a device backup was used to complete the surgery.

• Brand Name: MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• 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: 6430875
• MDR Text Key: 70741743
• Report Number: 0008031000-2017-00004
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• 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

• Date FDA Received: 03/24/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 89-8507-400-00
• Device LOT Number: 5005919
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 03/24/2017 Patient Sequence Number: 1