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

Model Number N/A

Device Problem Expulsion (2933)

Patient Problem Eye Injury (1845)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The product will not be 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 at the end of the intervention, the assistant opened the case to get rid of the batteries.He found that it was hot but not any more than usual.When the second batteries were removed, the case exploded.The assistant received some particulate in his eyes and had to see a doctor for security reason.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected.Review of the device history record for (b)(4), lot number z000006619, identified no relevant deviations or anomalies.Product examination could not be performed as no product was returned for this complaint.This complaint cannot be confirmed.The root cause of the reported event could not be specifically determined with the provided information.The product was not returned for examination.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: 6935894
• MDR Text Key: 89147640
• Report Number: 0001526350-2017-00723
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: Z000006619
• Other Device ID Number: (01)00889024375185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other