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

Catalog Number 00515047501

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the surgery the tip lock would slid easily by its own vibration while in use.It unlocked and the tip came off from the hand piece.There was no harm and delay was less than 15 minutes.No adverse events were reported as a result of this malfunction.

Event Description

No additional information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet.Visual inspection found the device was used.The handpiece trigger was left on and the battery pack was depleted there was no obvious damage on the device.Functional testing found that the device operated normally, and the tip lock slid easily.Device is used for treatment.The root cause of the reported issue is attributed to the tip lock thickness dimension being manufactured at the low end of the specification such that the interference condition with the slot width (post mold change) may not be sufficient with normal process variation.An action was initiated as a result of the investigation of this event.The event is confirmed.

• Brand Name: FAN SPRAY KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10171133
• MDR Text Key: 195762647
• Report Number: 0001526350-2020-00539
• 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: 10/15/2020

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: 08/31/2022
• Device Catalogue Number: 00515047501
• Device Lot Number: 64499734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1