MAUDE Adverse Event Report: ZIMMER SURGICAL S.A. UNIVERSAL 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 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the date of this report, the investigation was then not completed.A follow up medwatch will be submitted once the investigation is completed.

Event Description

It was reported that the trigger was blocked in "on" position and the device did not stop when the user released the trigger.There was not patient harm reported.The surgery was on a 15-minute delay.

Event Description

It was reported that the trigger was blocked in "on" position and the device did not stop when the user released the trigger.There was not patient harm reported.The surgery was on a 15-minute delay.

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4).Was returned for complaint investigation.Upon receipt, it was confirmed that the device does not stop due to sticky trigger, the motor was noisy and the controller board was observed defective.The front face (including trigger), motor and controller board were replaced.The battery support and heat shrink were replaced together with controller board.This information was reported in error under mfr #0008031000-2015-00113-2 on 18-jan-2016 (date that the initial mdr submitted in error was sent) with three additional 0¿s.This information is now being reported under manufacturing report #8031000-2015-00113-2.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL S.A.; chemin pre fleuri 3; plan les ouates, geneve CH 12 28; SZ CH 1228
• MDR Report Key: 5133970
• MDR Text Key: 27988871
• Report Number: 8031000-2015-00113
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Followup,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-00
• Device Lot Number: 5000254
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1