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

Model Number N/A

Device Problems Material Rupture (1546); Device Contaminated During Manufacture or Shipping (2969); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

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

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was initially reported that a pulsavac kit was pulled from hospital stock for a standard knee procedure.Before the package was opened, charcoal or debris was seen in the package that was not considered normal.The package was not used and replaced with another pulsavac unit without issue.Additional information was received on august 31, 2016 stating that the device was not used during surgery and that medical intervention/additional surgical procedure required.Incoming inspection was conducted on (b)(6) 2016, found that the device had a battery rupture in the carton unopened.

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).In the initial submitted medwatch stated that medical intervention was required.This information was incorrect.Also, it mentioned an initial inspection.The complete inspection and evaluation of the device is presented in this supplemental medwatch.The customers reported event was that the device did not work and is considered a complaint out of the box (coob).Review of the device history record for 00515042000, lot number 63302972, identified no deviations or anomalies.Product examination found that the battery inside the sealed packaging had overheated and ruptured.This complaint is confirmed.The reported event claimed that the sealed unit contained battery debris.While rare, this kind of event occurs when the batteries overheat from a short circuit.To address this issue, a notice has been implemented to adjust the length of the wires inside the battery pack.This means that there will no longer be a need to tightly fold wires inside the battery pack in order for them to reach their respective circuit contacts.This reduces the risk of a short circuit.However, the root cause cannot be specifically determined with the provided information as it is not clear what specifically led to the short circuit.

• Brand Name: COMPONENT 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: 6233771
• MDR Text Key: 64622116
• Report Number: 0001526350-2017-00009
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 07/12/2017

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: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 00515042000
• Device Lot Number: 63302972
• Other Device ID Number: 00889024380004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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