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); Intermittent Loss of Power (4016)

Patient Problem No Information (3190)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Complaint number (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 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) works intermittently, sometimes it works, sometimes it stops.The safety lock bottom locked in one position.The event occurred during knee arthroplasty.An extension of surgery of 60 minutes was reported due to the time needed to replace the device.The patient was under anesthesia at the time of the delay.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Complaint number (b)(4).Universal handpiece, part number 89-8507-400-00, serial number 459684, was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the device was working intermittently due to issue with potted wired controller and the selector was blocked.Moreover the motor was noisy.As repair, the motor, the front face and the potted wired controller were replaced.After repair, the device passed final tests and it was returned to the customer.Additional information: the initial report was submitted late (after 30 days) because the complaint was created late by the distributors.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece part number 89-8507-400-00 serial number 459684 works intermittently, sometimes it works, sometimes it stops.The safety lock bottom locked in one position.The event occurred during knee arthroplasty.An extension of surgery of 60 minutes was reported due to the time needed to replace the device.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
• MDR Report Key: 8854263
• MDR Text Key: 153062057
• Report Number: 0008031000-2019-00017
• 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: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• 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: 5011276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other