MAUDE Adverse Event Report: RELIGN CORPORATION 3 IN 1 SHAVER 4.2MM

Model Number	N/A
Medical Device Problem Codes	Flaked (1246); Peeled/Delaminated (1454); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 4.2mm relign 3-in-1 blades giving off metal flakes/shaving into the patient during knee scope.It is unknown at the moment as to whether all of the flakes were recovered.There was no reported patient harm, or delay.Due diligence is in process, no further information is available at this time.
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.Additional related reports: 0001526350-2024-00091.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device discarded.
Event or Problem Description
It was reported that the 4.2mm relign 3-in-1 blades giving off metal flakes/shaving into the patient during knee scope.The patient did not retain any of the foreign particles.There was no reported patient harm, or delay.Due diligence is complete.No further information is available.As no additional information is available, we are unable to provide further information.
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2024-00091-1 this medwatch is being filed to relay additional information.The following sections were updated/corrected: b1, b2, b4, b5, d4, g3, g6, h1, h2, h3, h4, h5, h6, h8, h10.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event cannot be 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: SHAVER
• Manufacturer (Section D): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18526104
• Report Number: 0001526350-2024-00090
• Device Sequence Number: 6469455
• Product Code: HRX
• UDI-Device Identifier: 00859273007083
• UDI-Public: (01)00859273007083(17)250331(10)F23C31-12
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 03/14/2024

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: R10008
• Device Lot Number: F23C31-02
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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
• 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: Prefer Not To Disclose