MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC PLUS HIP SINGLE; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM

Model Number N/A

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Event Description

It was initially reported that during surgery, the product didn't work.Therefore, the nurse opened an alternative one to complete the surgery.Additional information received on (b)(6) 2016 stated that the motor didn't work when the switch was in the high or low mode position and that the battery was leaking.It also confirmed there was no harm, injury, or adverse event to the patient or operator.The event happened during surgery causing a 0-15 minute delay in the procedure.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the device history record could not be performed as no lot number was reported for this complaint.Product examination found that the battery pack had been damaged from leaking batteries, as shown in attached photos.The leak had caused a few of the battery contacts to become corroded.The corroded battery contacts prevented the device from being tested.This complaint is confirmed.While it was found during inspection that the battery pack had been damaged from the leaking batteries, it cannot be determined what caused the batteries to leak.Furthermore, since the batteries caused the battery contacts to become corroded, the device could not be tested to verify the reported motor not functioning issue.Therefore, the root cause of the leaking batteries and the motor not working cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: PULSAVAC PLUS HIP SINGLE
• Type of Device: DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6177799
• MDR Text Key: 62867807
• Report Number: 0001526350-2016-00148
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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: 00515048201
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00889024375192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1