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

Catalog Number	R10001
Medical Device Problem Codes	Material Frayed (1262); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, the pedals or buttons on footswitch no worked, changed over footswitch and all ok.On further inspection there were some exposed wires on the cable, metal and colored wires were visible.There was no patient harm/injury or surgical delay as there was no patient involvement.Due diligence is complete, no further information is available.There was no adverse event associated with this malfunction.
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2 country: australia.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected.Review of the most recent repair record determined the footswitch cable was cut.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 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: 20599192
• Report Number: 3012790575-2024-00007
• Device Sequence Number: 18344072
• Product Code: HRX
• UDI-Device Identifier: 00859273007014
• UDI-Public: (01)00859273007014(11)230518
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Catalogue Number: R10001
• Device Lot Number: N/A
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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: FOOTSWITCHPN: FS10001SN: (B)(6)LN: UNK; UNK 3-IN-1 SHAVERPN: UNKSN AND LN: UNK; UNK EXOFLOWPN: UNKSN AND LN: UNK; UNK HANDPIECEPN: UNKSN AND LN: UNK
• Patient Sex: Prefer Not To Disclose