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

Catalog Number 89-8507-400-10

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 01/19/2019

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 single trigger handpiece part number 89-8507-400-10 serial number (b)(6) stopped during total knee procedure.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.

Event Description

It was reported that the universal modular electric/battery single trigger handpiece part number 89-8507-400-10 serial number (b)(4) stopped during total knee procedure.A delay in the sugery 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.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(4), was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it has been confirmed that the device was not functional due to issue with potted wired controller.Moreover, the motor was noisy.As a repair, the potted wired controller, the motor were replaced.After repair, the device passed final inspection and was returned to the customer.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 8315371
• MDR Text Key: 135372000
• Report Number: 0008031000-2019-00013
• 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: 04/26/2019

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: 89-8507-400-10
• Device Lot Number: 5008971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other