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

Model Number	N/A
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that metal powder came out from the device during surgery.No foreign bodies were retained.There was no reported harm or injury to the patient.A non specific delay of approximately 15 minutes was reported for preparing a back up of the same device which was use to complete the procedure.No adverse event was reported.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2:foreign: japan.The following sections have been updated: a1, b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, h10.Based on the investigation, the 3-in-1 shaver 5.0mm was observed with striations on the inner sheath tip which is evidence of metal particulate generation.The risk of future occurrences has already been reduced by the design process updates implemented in rel1463 (particularly the material changes from 17-4 stainless steel to nitronic-60 stainless steel).It is recommended to disposition the complaint 3-in-1 shaver 5.0mm as scrap.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to interaction between the inner and outer tube tips.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
No additional information is available regarding the incident.

• Brand Name: 3 IN 1 SHAVER 5.0MM
• 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: 17077904
• Report Number: 3012790575-2023-00002
• Device Sequence Number: 6273635
• Product Code: HRX
• UDI-Device Identifier: 00859273007144
• UDI-Public: (01)00859273007144(17)231122(10)F21L22-02
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2023
• Device Model Number: N/A
• Device Catalogue Number: R10014
• Device Lot Number: F21L22-02
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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
• 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
• Patient Sex: Prefer Not To Disclose