MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN; KNEE INSTRUMENTS

Catalog Number	00590102000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - japan.Customer has indicated that the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Suggested component code: mechanical (g04) - drill.
Event or Problem Description
It was reported when inserting the fourth hdless trc drill pin (diagonal hole) of the cut block, the connector part of the headless pin broke while remaining in the pin adapter.An attempt was made to remove the pin remaining in the cut guide using a pin extractor but was unable to do so.When an attempt was made to remove the pin using a chuck and power (reverse rotation), the pin broke further in the center.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d4; g3; h2; h3; h6.The following sections was corrected: h4.Visual examination of the provided pictures identified signs of use on the pin (nicks/gouges).The pin has fractured into 3 parts.Images of the cut guide were also provided but did not confirm any particular failure.Further evaluation could not be performed as the devices were not returned.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.These devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is confirmed.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.

• Brand Name: NEXGEN
• Common Device Name: KNEE INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23486224
• Report Number: 0001822565-2025-04012
• Device Sequence Number: 21414957
• Product Code: LXH
• UDI-Device Identifier: 00889024201620
• UDI-Public: (01)00889024201620(17)350530(10)67207569
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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: 00590102000
• Device Lot Number: 67207569
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 05/13/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 02/26/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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
• Patient Sex: Unknown