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

Catalog Number 89-8507-400-00

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 11/13/2018

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 if any additional information is received.

Event Description

It was reported that the electric/battery double trigger handpiece part number 89-8507-400-00, serial number (b)(4) would not turn on during surgery.It was reported that a few minutes of delay occured with the indication that this delay was higher to 30 minutes due to the time needed to change the device.No additional information was provided.There was no other harm or injury to patient/operator reported.

Manufacturer Narrative

Zimmer biomet complaint.Additional information was received regarding the time of the delay.It was initially reported that a few minutes of delay occured with the indication that this delay was higher than 30 minutes due to the time needed to change the device.Additional information was received that the delay of the surgery was actually less than 30 minutes.Therefore this complaint is reassessed as non-reportable.

Event Description

It was reported that the electric/battery double trigger handpiece part number 89-8507-400-00 serial number (b)(4) would not turn on during surgery.It was reported that a few minutes of delay occured with the indication that this delay was higher to 30 minutes due to the time needed to change the device.No additional information was provided.There was no other harm or injury to patient/opeartor 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: 8202257
• MDR Text Key: 131582790
• Report Number: 0008031000-2018-00030
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: 5005466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other