MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE

Catalog Number TPSS100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Upon receipt of additional information and the investigation is complete, a follow up/final report will be submitted.

Event Description

It has been reported that the safety station was not functional with all the leds lit on the control board and there was a burning smell.The event timing was during cleaning and therefore there was no patient involvement or delay in treatment.No adverse events were 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.The previous repair record for transposal safety station serial number (b)(6) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) hospital that all the leds lit on the control board and there was a burning smell.On (b)(6) 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.On (b)(6) 2019, the technician arrived at the site and confirmed the reported event when the unit was plugged in.He replaced main control board (part #14499-6, lot code 0028054) to resolve the issue and found the flow sensor (pn 91220) needed replaced as well, then verified that the cart was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.The root cause for the reported event was due to a malfunctioning control board.The control board operates the general electronics of the unit, and when malfunctioning can cause a variety of issues, such as failing to begin the cleaning cycle or failing to recognize canisters.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the control board and flow sensor were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.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 any adverse trends that may warrant further action.H3 other text : product evaluated by external contractor.

Event Description

It was reported that during cleaning the safety station was not functional with all the leds lit on the control board and there was a burning smell.There was no patient involvement.No adverse events have been reported as a result of this malfunction.

• Brand Name: TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: TRANSPOSAL SAFETY STATION
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9497940
• MDR Text Key: 197310953
• Report Number: 0001526350-2019-01177
• Device Sequence Number: 1
• Product Code: FLH
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: TPSS100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1