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

Catalog Number 89-8507-400-00

Device Problems Partial Blockage (1065); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2018

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 additionnal information is received.

Event Description

It was reported that the universal electric/battery double trigger handpiece (b)(4) serial number (b)(4) was blocked and not functional.The surgery delay was 70 minutes and the patient was under anesthesia.The reason of delay of the time needed to search for another handpiece.Additional anesthesia was prescribed.There was no additional harm or injury to patient/operator reported.

Event Description

It was reported that the universal electric/battery double trigger handpiece (b)(4) serial number (b)(4) was blocked and not functional.The surgery delay was 70 minutes and the patient was under anesthesia.The surgery was a hip replacement surgery.The reason of delay of the time needed to search for another handpiece.Additional anesthesia was prescribed.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece, serial number (b)(4) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the trigger board connector was defective, the motor was noisy and the wire connecting the trigger board to the controller board was defective.The defect reported by the customer ("bloqued & not functional") was confirmed because the device was not functional due to the defective wire connecting the trigger board to the controller board.As a repair, the motor and the potted wire controller kit were replaced.Final tests were performed and the device was returned to the customer.

• Brand Name: UNIVERSAL ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri,3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• MDR Report Key: 7376515
• MDR Text Key: 103650540
• Report Number: 0008031000-2018-00014
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-00
• Device Lot Number: 5006423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 75