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

Catalog Number 89-8507-400-00

Device Problems Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned at the time of this report.However, a follow up medwatch will be submitted once the investigation is completed.

Event Description

It is reported that the universal modular electric/battery double trigger handpiece serial number (b)(4) keeps running after switching it off.There was no patient harm or delay reported.

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece, serial number (b)(4) has been returned for complaint investigation.Upon receipt, it has been confirmed that the problem could not be reproduced.Though, the motor was seized and the wire connecting the trigger board and the electronic controller board was defective at the level of the connections.The motor and the aforementioned wire have been replaced.The product has been returned to the customer.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin pre fleuri 3; plan les ouates, geneva CH 12 28; SZ CH 1228
• Manufacturer Contact: cecile guiot ; chemin pre fleuri 3; plan les ouates, geneva CH 12-28 ; SZ CH 1228 ; 7062106
• MDR Report Key: 4987872
• MDR Text Key: 22435816
• Report Number: 8031000-2015-00090
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 89-8507-400-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1