MAUDE Adverse Event Report: RELIGN CORPORATION SHAVER HANDPIECE ATCLV; ARTHROSCOPE

Model Number N/A

Device Problems Overheating of Device (1437); Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 10/04/2023

Event Type  Injury  

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.Multiple mdr reports were filed for this event, please see associated reports: 3012790575-2023-00009.

Event Description

It was reported that during surgery, the 3 in 1 shaver overheated and burned the patients arm.The patient had a burn in the shape of the shaver on their arm.There was no delay in the procedure.Due diligence is in process and there is no additional information available.

Event Description

It was reported that during surgery the 3 in 1 shaver overheated and burned the patient's arm.The surgeon and physicians' assistant closed the incisions and working portals in a standard fashion.Sutures were not required to close the burn damage.There was no operator impact due to the device overheating.It is unknown what degree burn the patient was diagnosed with.Due diligence is complete and there is no additional information available.

Manufacturer Narrative

This complaint is recorded by zimmer biomet 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.Multiple mdr reports were filed for this event, please see associated reports: 3012790575-2023-00009-1.

Event Description

There is no further information available regarding the event.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).The complaint was not confirmed.Based on the investigation, no fault was found related to the complaint description of a patient ¿burn¿.The complaint handpiece was the only device returned from the tricera system so a complete investigation on the functionality of the tricera system could not be determined.There are other factors that could also have caused the patient burn such as the environment, surgical / user setup, and misuse by the user but there is no evidence to support these as root causes.Therefore, the root cause is unknown.It is recommended to disposition the complaint handpiece as scrap.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be 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.

• Brand Name: SHAVER HANDPIECE ATCLV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer (Section G): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18030403
• MDR Text Key: 326860760
• Report Number: 3012790575-2023-00008
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00859273007236
• UDI-Public: (01)00859273007236(11)211022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K233493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: R10023
• 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
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: R10001TRICERA CONTROLLER(B)(6)
• Patient Outcome(s): Other
• Patient Sex: Male