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

Catalog Number 89-8507-400-00

Device Problems Mechanical Problem (1384); Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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 if any 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) stopped working during the surgery while surgeon was cutting the distal femur bone.A delay of surgery was reported between 31-60 minutes.The patient was under anesthesia.A handpiece of johnson & johnson's company was then used to complete the surgery.There was no additional harm or injury to the patient reported.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Universal modular electric/battery double trigger handpiece part number 89-8507-400-00, serial number (b)(6), was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, the event reported by the customer was confirmed as the lower trigger was blocked, the motor was noisy and malfunctioning.Besides, device had a leakage issue and potential traces of corrosions were detected at the motor.As a repair, motor was replaced with the potted wired controller and the battery support.After repair, the device passed final tests and it was returned to the customer.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(6) stopped working during the surgery while surgeon was cutting the distal femur bone.A delay of surgery was reported between 31-60 minutes.The patient was under anesthesia.A handpiece of johnson & johnson's company was then used to complete the surgery.There was no additional harm or injury to the patient reported.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLETRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLETRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3 chemin du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• MDR Report Key: 8314146
• MDR Text Key: 135342339
• Report Number: 0008031000-2019-00012
• 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
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• 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: 5007515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other