MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

Model Number N/A

Device Problems Device Emits Odor (1425); Battery Problem (2885); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.

Event Description

It was reported that the pulsavac handpiece started to heat after connecting of the battery unit.Batteries heated also.Battery unit and handpiece smelled like burned plastic.The event occurred before the surgery started.Product has not contaminated, package is opened but item is not used, removed from or before operation has started.No adverse event was reported as a result of this event.

Event Description

It was reported that the pulsavac handpiece started to heat after connecting of the battery unit.Batteries heated also.Battery unit and handpiece smelled like burned plastic.

Manufacturer Narrative

Visual examination of the returned product/provided pictures identified the device was returned used, as there was still fluid in the tubing and suction.Visual inspection found the cord and wires had been pulled out of the battery pack.Upon opening the pack it was discovered the rest of the wiring was missing from the pack, therefore functional testing could not be completed.No other damage was found.Lot identification is necessary for review of device history records, and lot identification was not provided.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item.However, as the lot number is unknown, an additional review could not be performed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11405965
• MDR Text Key: 242919017
• Report Number: 0001526350-2021-00234
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1