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); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 11/11/2020

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 sent if the product is returned 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) worked on and off both on battery and power cable.The event occurred during surgery.An extension of surgery of 60 minutes was reported due to the time needed to replace the device.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

(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 device was not functional due to seized motor.Moreover, the controller board wires were damaged.The reported event was confirmed.No repair was performed due to not answered quotation from the customer.Device was sent back to customer unrepaired with a discharge letter.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece part number: 89-8507-400-00, serial number: (b)(6) works on and off both on battery and power cable.The event occurred during surgery.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: 10913791
• MDR Text Key: 218514567
• Report Number: 0008031000-2020-00009
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• 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: 5011039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other