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

Model Number N/A

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).(b)(4).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that before surgery the battery had exploded in the packaging.There was black dust in the packaging.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This follow-up report is being submitted to relay additional information.Review of the device history record identified no relevant deviations or anomalies.Product examination found that the unit had ruptured inside the sterile packaging before use.This complaint is confirmed.The root cause of the reported event is a short circuit of the battery.The source of the short could not be identified as the damage caused by the rupture was too extensive.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 6765096
• MDR Text Key: 81852312
• Report Number: 0001526350-2017-00453
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: Z000006612
• Other Device ID Number: (01)00889024375185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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