MAUDE Adverse Event Report: RELIGN CORPORATION 3 IN 1 SHAVER 5.0MM; ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery on (b)(6) 2023, patient was burnt by the relign shaft.Patient was burnt during procedure but there was no reported surgical intervention and no delay in the procedure.Continuing due diligence to confirm if additional treatment measures occurred.No additional consequences have been reported as a result of this malfunction.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.
Additional Manufacturer Narrative
It has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was created in error and should be voided.
Event or Problem Description
It has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was created in error and should be voided.

• Brand Name: 3 IN 1 SHAVER 5.0MM
• Common Device Name: ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES
• 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: 17332883
• Report Number: 3012790575-2023-00003
• Device Sequence Number: 6608087
• Product Code: HRX
• UDI-Device Identifier: 10859273007141
• UDI-Public: (01)10859273007141(17)240628(10)F22F28-02
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162770
• 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
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2024
• Device Model Number: N/A
• Device Catalogue Number: R10014
• Device Lot Number: F22F28-02
• Was Device Available for Evaluation?: No
• 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: 06/18/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female