MAUDE Adverse Event Report: RELIGN CORPORATION TRICERA CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Device Difficult to Program or Calibrate (1496); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that during surgery the tricera controller would not stay at the preset settings.Adjustments were required every procedure and during cases.There was no patient involvement with no harm or delay reported.The foot switch stopped working and upon inspection showed exposed metal wiring.Diligence is complete.No additional information is available.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d9, g3, g6, h2, h6, h11.Once the investigation is complete, a follow up/final report will be submitted.
Event or Problem Description
It was reported that during surgery the tricera controller would not stay at the preset settings but was struggling to maintain pressure settings under the surgeons saved profile.Pressure was manually adjusted to the surgeon preference baseline at each case.Furthermore, the foot switch stopped working and upon inspection showed exposed metal wiring.There was no harm or delay reported.Diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, d9, d10, g1, g3, g6, h1, h2, h3, h4, h6, and h11.Review of the most recent repair record determined the controller was found to have a damaged chassis preventing the cassette from properly latching; however, the repair was not completed because the unit is to be dispositioned as scrap review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
There is no additional information available regarding the event.

• Brand Name: TRICERA CONTROLLER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19604932
• Report Number: 3012790575-2024-00005
• Device Sequence Number: 3266347
• Product Code: HRX
• UDI-Device Identifier: 00859273007014
• UDI-Public: (01)00859273007014(11)210803
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K233493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: R10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 10/15/2024; 11/26/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 10/28/2024; 11/13/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FOOTSWITCH.RPLCMNT.FS10001.SN: (B)(6); R10001.TRICERA CONTROLLER.; TRICERA FOOT SWITCH.PN R10005.SN UNKNOWN.
• Patient Sex: Prefer Not To Disclose