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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

The locking ring happened loosing cant lock debridement tip then leaking also appear lower power during surgery.There was no harm or delay.The tip come off of the hip kit.There was no adverse event reported as a result of this malfunction.

Event Description

There is no additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Functional testing determined the device powered on and functioned normally when connected to a battery pack from the lab.The tip lock and tip stayed in place during testing.Visual inspection did not find any damage.The device was returned used , as there was fluid in the tubing and suction.The original battery pack was not returned with the package.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

• 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: 11391627
• MDR Text Key: 234054512
• Report Number: 0001526350-2021-00230
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/06/2021

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: 64676749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1