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

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: (b)(6).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.
Event or Problem Description
It was reported that outside of surgery a foreign substance was found in the sterile packaging.There was no patient involvement.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The shaver was returned new in package.Visual inspection confirmed there was debris measuring approximately.80mm squared sealed inside the product pouch.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a manufacturing deficiency.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.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information the shaver was returned new in package.Visual inspection confirmed there was debris measuring approximately.80mm squared sealed inside the product pouch.The debris found within the pouch is likely cloth fiber from the operator.
Event or Problem Description
No additional information is available.

• 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: 19286984
• Report Number: 3012790575-2024-00004
• Device Sequence Number: 7734678
• Product Code: HRX
• UDI-Device Identifier: 00859273007083
• UDI-Public: (01)00859273007083(17)251225(10)F23M25-01
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2024

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: 12/25/2025
• Device Model Number: N/A
• Device Catalogue Number: R10008
• Device Lot Number: F23M25-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 09/05/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/11/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2023
• 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
• Patient Sex: Prefer Not To Disclose