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

Catalog Number 89-8507-400-00

Device Problem Self-Activation or Keying (1557)

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

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported that the double trigger handpiece was running without action on the triggers.No patient harm or injury has been reported.No surgery delay has been reported.

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 problem could not be reproduced.Though, the wire connecting the trigger board and the controller board was defective, the motor flange was unstuck, the battery support was cracked and that the motor was noisy.The wire, the motor, the battery support and the controller board were replaced.The product was returned to the customer.This information was reported in error under mfr #0008031000-2015-00106-1 on 15-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 #8031000-2015-00106-1.

Event Description

It was reported that the double trigger handpiece was running without action on the triggers.No patient harm or injury has been reported.No surgery delay was reported.

• 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
• MDR Report Key: 5059615
• MDR Text Key: 25781960
• Report Number: 8031000-2015-00106
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-00
• Device Lot Number: 5002285
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2015
• Initial Date FDA Received: 09/07/2015
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1