MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. STANDARD SHAVER 3.4MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	R10012
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the device had left a diamond dust (debris) in the soft tissue after use.There was no patient impact but there was a delay of an amount of time.Due diligence is in process and there is no additional information available.
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 telephone number: (b)(6).G2 country: thailand.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, g1, g3, g6, h1, h2, and h11.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
It was reported that during surgery the device had left a diamond dust (debris) in the soft tissue after use.The debris was successfully removed and no additional surgery was needed.There was a delay of 30 minutes while the debris was being removed.Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, h10 and h11.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 reported event is not 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
There is no additional information available regarding the event.

• Brand Name: STANDARD SHAVER 3.4MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• 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: 23414794
• Report Number: 0001526350-2025-01378
• Device Sequence Number: 15689684
• Product Code: GEI
• UDI-Device Identifier: 00859273007120
• UDI-Public: (01)00859273007120(17)270304(10)F25C04-01
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup
• Report Date (Section B): 03/30/2026

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 Catalogue Number: R10012
• Device Lot Number: F25C04-01
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/09/2025; 03/17/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/05/2025; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: R10017.EXOFLOW CASSETTE.F25C14-01.; R10017.EXOFLOW CASSETTE.F25C25-01.
• Patient Sex: Unknown