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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned, at the time of the submission of this report, but it was not evaluated yet.A follow up medwatch will be submitted once the investigation is completed, including results of visual and functional tests performed on the product.

Event Description

It was reported that the universal electric/battery double trigger handpiece stop working during a surgery.The surgery was delayed for more than 30 minutes, the exact surgery delay time is unknown.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 wire connecting controller board to trigger board was defective.The reported defect by the customer (device stopped working during the surgery) was confirmed.As a result the above wire was replaced.After repair, the product was tested, inspected as per internal processes and it was returned to the customer.

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece serial number 311179 was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the wire connecting controller board to trigger board was defective.The reported defect by the customer (device stopped working during the surgery) was confirmed.As a result the above wire was replaced.After repair, the product was tested, inspected as per internal processes and it was returned to the customer.Additional information was received about availability of the backup device for the completion of the surgery.The backup device was available and was used to complete the surgery.Time of the delay remains unknown.

• 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 (Section G): ZIMMER SURGICAL SA; SZ
• Manufacturer Contact: jennifer hutchison ; chemin pré fleuri 3; plan les ouates, geneva ; 3438801000
• MDR Report Key: 5927953
• MDR Text Key: 53908825
• Report Number: 0008031000-2016-00010
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• 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: 5004638
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• 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