MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 3.5MM HEX DRIVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	31-301852
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 foreign: spain.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.
Event or Problem Description
It was reported that the product is broken from the warehouse.No patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were update/corrected: a1, a5, b5.
Event or Problem Description
It was reported that the product is broken.The event occurred during a revision surgery where competitor devices were removed and replaced with zimmer biomet devices.No piece fall in patient; the product was found broken.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were update/corrected: d4 lot number was corrected.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d4; h2; h3; h4; h6.Visual examination of the provided picture identified the hex driver has fractured at the tip.Device not returned, further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARCOS 3.5MM HEX DRIVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23220355
• Report Number: 0001825034-2025-03099
• Device Sequence Number: 9906081
• Product Code: KWA
• UDI-Device Identifier: 00880304484498
• UDI-Public: (01)00880304484498(11)190626(10)Z19D0651
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K090757
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/16/2026

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: 31-301852
• Device Lot Number: Z19D0651
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 01/14/2026; 01/27/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/20/2025; 01/14/2026; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• 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
• Patient Sex: Unknown