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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during discarding it, the nurse found some liquid leaked from the batteries.This incident was found before cutting the cable.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This follow up report is being submitted to report additional information.Medical device - udi - (b)(4).Review of the device history record for 00515048201, lot number z000009909, identified no relevant deviations or anomalies.Product examination found that only the battery pack was returned for this complaint.The batteries inside the battery pack had ruptured due to a short circuit.This complaint is confirmed.However, the wire was cut by the customer.A review using the p/n of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿leak¿ between (b)(6) 2017 to (b)(6) 2018 resulted in 9 complaints.A review using the criteria of p/n and complaint category of this complaint and also based upon open and closed complaints and the keyword search using the character string ¿leak¿ and sorted by manufacturer date was performed.This review resulted in the highest occurrence for a given manufacture date was 2.Reviewing the complaints for the lot number z000009909 shows 1 complaints for this part and lot number.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ the root cause of the reported event could not be specifically determined with the provided information.It is unknown how or when this particulate became present on this device.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 discarding it, the nurse found some liquid leaked from the batteries.This incident was found before cut the cable.Therefore, this incident has nothing to do with cable cutting.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7596304
• MDR Text Key: 110910659
• Report Number: 0001526350-2018-00548
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: Z000009909
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1