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

Catalog Number 00515047501

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).The investigation is still in progress.Once the investigation is complete a final mdr will be submitted.(b)(4).Report source - foreign - (b)(6).

Event Description

It was reported that during the surgery, this product didn't spray saline water as usual.The cord was cut.There was a 0-15 minute delay to prepare an additional product.There was no harm to patient.No adverse events were reported as a result of this malfunction.

Event Description

No additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi#: (b)(4).Dhr review: the device history record (dhr) for 00515047501 lot number 64391867, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Technical review and physical evaluation: on 10 february 2020, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device was returned with the power cord and debridement tubing cut.The results of the returned product investigation could not confirm the reported event.Probable cause/root cause: the reported event could not be confirmed as the device was returned with the tubing and power cable cut.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

• 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: 9590396
• MDR Text Key: 195411781
• Report Number: 0001526350-2020-00061
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 00515047501
• Device Lot Number: 64391867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1