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

Catalog Number	R10005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident is being recorded under (b)(4).Once investigation is complete a supplemental/final report will be submitted.G2: foreign: japan.E1: telephone: (b)(6).
Event or Problem Description
It was reported that during surgery fractured pieces of the tip of the dynablator (ceramic part) remained temporally in the patient's body.The surgery of arcr was performed with the dynablator.It was noticed that 2 foreign substances had remained in the patient's body by x-ray after the surgery, but the surgeon didn't remove them at that time.On (b)(6) 2025, surgery was performed to remove the 2 foreign substances from the patient's body.All of the pieces were removed.No additional information was noted as a result diligence is complete.
Event or Problem Description
No additional event information is available.
Additional Manufacturer Narrative
The following sections were updated b4 b5 g3 g6 h2 h3 h4 h6 h11.Visual examination of the provided pictures identified that the photos provided are fragments of the dynablator tip.Based on the damage observed in the photos, excessive force resulted in the tip breakage.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a user error.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.

• Brand Name: DYNABLATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & 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: 22436956
• Report Number: 3012790575-2025-00002
• Device Sequence Number: 16931780
• Product Code: GEI
• UDI-Device Identifier: 10859273007059
• UDI-Public: (01)10859273007059(17)260902(10)F24J02-04
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/19/2025

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
• Device Expiration Date: 09/02/2026
• Device Catalogue Number: R10005
• Device Lot Number: F24J02-04
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown