MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 8X23MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	231817
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from china that during an unspecified surgical procedure it was observed that the milagro advance screw 8x23mm anchor broke off.It was reported that all the broken parts were removed.Another like device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.Investigation summary :the product was returned to j&j medtech orthopaedics for evaluation.J&j medtech orthopaedics then conducted visual inspection of the device received.Visual inspection reveled that the milagro advance screw 8x23mm threads are noticeably stripped, also they show some broken areas.Not all broken anchor threads fragments were returned.The overall complaint was confirmed as the observed condition of the milagro advance screw 8x23mm would have contributed to the complained device issue.Based on the investigation findings, the potential root cause can be traced to procedural variables, such handling of the device or product interaction during procedure; resistance may have been felt when the device was being inserted and the excessive force applied caused the anchor damage.As per instructions for use (ifu); if resistance is felt during the insertion of a milagro br interference screw over a guidewire, stop and confirm that the guidewire is not entrapped.If entrapped, back out the screw and withdraw the guidewire.Therefore 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 j&j medtech orthopaedics 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.¿.

• Brand Name: MILAGRO ADVANCE SCREW 8X23MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20534133
• Report Number: 1221934-2024-03828
• Device Sequence Number: 15123845
• Product Code: MAI
• UDI-Device Identifier: 10886705022250
• UDI-Public: (01)10886705022250(10)214L018(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• 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 Expiration Date: 07/31/2026
• Device Catalogue Number: 231817
• Device Lot Number: 214L018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown