MAUDE Adverse Event Report: ZIMMER SURGICAL SA MODULAR 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 02/20/2018

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer at the date of this report.A follow up medwatch will be submitted once the investigation is completed or if additional information is received.

Event Description

It was reported that the modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4) was blocked and not functional.During the total hip replacement surgery, a delay of 65 mins was reported as device was replaced for another one to finish the surgery.Due to this delay more anesthesia had to be applied to the patient.No other harm or injury was reported to patient/operator.

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 motor was noisy, the wire connecting the trigger board to controller board as well as the locking system between the attachment and the handpiece were defective.The event reported by the customer (bloqued & not functional) was confirmed.Following the instructions of the customer, the device was returned unrepaired with a discharge letter.

• Brand Name: MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• MDR Report Key: 7376699
• MDR Text Key: 103652106
• Report Number: 0008031000-2018-00012
• 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
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 5004935
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 80