MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 10X23MM; SCREW, FIXATION, BONE

Catalog Number	231819
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery doctor used screw during the acl repair procedure.Upon opening and inspection of the implant, it was observed that the thread of the screw appeared partially broken/damaged.Hence, the screw could not be used for the procedure.Another screw was subsequently used, and the surgery was completed successfully without any issue.There was no adverse effect on the patient.The concerned implant is available for inspection.Was there any reported patient or user harm? no.Was there a significant delay? no if available, provide the product order number (po).## ***.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the screw had signs of usage, and it was stripped at distal end.The device had foreign matter, so it cannot be confirmed that the device was not used.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the milagro advance screw 10x23mm would have contributed to the complained device issue.Based on the investigation findings, resistance may have been felt when the device was being inserted and the excessive force applied caused the screw to damage.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.There was no non-conformance regarding this lot.

• Brand Name: MILAGRO ADVANCE SCREW 10X23MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25599386
• Report Number: 1221934-2026-02753
• Device Sequence Number: 20184826
• Product Code: HWC
• UDI-Device Identifier: 10886705022236
• UDI-Public: (01)10886705022236(10)309L087(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 231819
• Device Lot Number: 309L087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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 Sex: Unknown