MAUDE Adverse Event Report: RELIGN CORPORATION 3 IN 1 SHAVER 4.2MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	N/A
Medical Device Problem Codes	Flaked (1246); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery pieces of the device came off and entered the patients surgery site.It is unknown if all pieces were removed.Another device was used to finish the procedure and as a result a delay occurred in which the patient was under anesthesia.No other adverse events were reported as it relates to this event.
Additional Manufacturer Narrative
This incident has been recorded under (b)(4).Upon completion of investigation a final/supplemental report will be submitted.
Event or Problem Description
No additional event information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under cmp-0837910.This medwatch is being filed to relay additional information.Visual inspection of the device confirmed there was abrasive wear on the mating surfaces of the inner and outer tube tips and metal transfer from the inner/outer tube tips to the ceramic insulation insert.The wear observed is typical as compared to durability tested validation units and does not affect the form, fit or function of the device.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to typical wear of the device.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: 3 IN 1 SHAVER 4.2MM
• 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: 15447758
• Report Number: 3012790575-2022-00005
• Device Sequence Number: 4622561
• Product Code: HRX
• UDI-Device Identifier: 00859273007083
• UDI-Public: (01)00859273007083(17)231104(10)F21L04-01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 11/04/2023
• Device Model Number: N/A
• Device Catalogue Number: R10008
• Device Lot Number: F21L04-01
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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: Unknown