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

Catalog Number 89-8507-400-00

Device Problems Partial Blockage (1065); Device Operates Differently Than Expected (2913)

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

Event Date 12/10/2016

Event Type  Injury  

Manufacturer Narrative

The 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 the controller board to the trigger board and the connector of the trigger board were defective.Besides, the motor was noisy.The event reported by the customer was confirmed.As repair, wire connecting the controller board to the trigger board, motor and trigger board were replaced with controller board.Then, the product was returned to the customer.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece was blocked and not functional.The surgery delay was 45 minutes because there was no substitute available during the operation.There was no additional harm or injury to patient/operator reported.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece was blocked and not functional.The surgery delay was 45 minutes due to the search of a substitute for the handpiece.There was no additional harm or injury to patient/operator reported.

• 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: 6263046
• MDR Text Key: 65212726
• Report Number: 0008031000-2017-00003
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: MO
• 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: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• 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: 5006857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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