MAUDE Adverse Event Report: BIOMET MICROFIXATION SCREW 2.0X10MM CROSS-DRIVE; PLATE, FIXATION

Catalog Number	41-2010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in colombia.The 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 during the implantation of a straight plate, two screws fractured.There was no known impact or consequence to the patient at the time of this report.Attempts have been made, and no further information has been provided.
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: a1; d4; d9; e1; g3; h2; h3; h4; h6; h10 and h11.Complaint sample was evaluated, and the reported event was confirmed.Visual inspection confirmed that the one returned screw has fractured.The customer reported two screws and only one was returned.The screw was analyzed using an optical microscope scanning electron microscope with x-ray spectroscopy (eds).The cross-drive screw fracture surface displayed fracture features that indicate a suspected torsional overload mode of fracture.Semi-quantitative eds revealed that the elemental composition is consistent with ti-6al-4v, titanium alloy.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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: SCREW 2.0X10MM CROSS-DRIVE
• Common Device Name: PLATE, FIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23769569
• Report Number: 0001032347-2025-00454
• Device Sequence Number: 13199162
• Product Code: JEY
• UDI-Device Identifier: 00888233000277
• UDI-Public: (01)00888233000277(10)J7887057
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081067
• 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
• Report Date (Section B): 05/28/2026

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: 41-2010
• Device Lot Number: J7887057
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 70 KG