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

Catalog Number 89-8507-400-00

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Handpiece (3067)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 03/23/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer at the date of this report. A follow-up medwatch will be submitted once the investigation is completed or additional information is received.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) "did not work despite the battery change and the cable plugging". An extension of surgery between 30 minutes and 1 hour was reported and the patient was under anesthesia. The extension of surgery is due to the time needed to replace the device. There was no additional harm or injury to patient/operator 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 du pré fleuri, 3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; chemin du pré 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: 8513469
• MDR Text Key: 141903836
• Report Number: 0008031000-2019-00014
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/15/2019
• 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: 5005618
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 04/15/2019 Patient Sequence Number: 1