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

Model Number N/A

Device Problems Corroded (1131); Expulsion (2933)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of the device history record for 00515048200, lot number z000007759, identified no relevant deviations or anomalies.Product examination found that the battery pack had failed because a battery had leaked.This caused corrosion of the battery contacts.This complaint is confirmed.The root cause of the reported event was due to the battery leaking and corroding the battery contacts.It was found during evaluation that the battery failed and had leaked, corroding the battery contacts.The corroded contacts would prevent the battery from then supplying the necessary power to the device and therefore cause the pulsavac to not function as intended.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that during surgery the zimmer pulsavac plus stopped working after 15 seconds.Initial inspection of the returned device revealed that the battery failed and had leaked, corroding the battery contacts.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• 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: 7277302
• MDR Text Key: 100516856
• Report Number: 0001526350-2018-00154
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PEXEMPT
• 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
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: Z000007759
• Other Device ID Number: 00889024375185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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