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)

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.

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, it was confirmed that the motor was noisy and seized.Besides, the selector was blocked.As repair, motor was replaced with the front face.  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) "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
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other