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

Catalog Number 89-8507-400-00

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is submitted late due to an oversight: the delay of surgery of 45 minutes was not correctly assessed at the time of the reception of the information on the 6th of august 2020.Universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4), was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the device was not functional due to seized motor.Moreover, the trigger was loose and the motor screws were broken.The event reported by the customer was reproduced.The device was not repaired as the quotation was not approved by the customer.The device was sent back to the customer unrepaired with a discharge letter also, a device history records review was performed for this product part number 89-8507-400-00 serial number (b)(4).No issue was found during the manufacturing process that could explain the defect reported.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4), suddenly stopped running during a total knee replacement surgery.A delay in the surgery procedure of 45 minutes was reported.The reason for the delay was the time needed to sterilize another handpiece to complete the surgery.The patient was under anesthesia at the time of the delay.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; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11285364
• MDR Text Key: 230462080
• Report Number: 0008031000-2021-00002
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: KE
• 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
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 5006653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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