MAUDE Adverse Event Report: DEPUY MITEK LLC US 5X12 MILAGRO INTERERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	231814
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative:.
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H4: unknown.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device is shown in used condition.The device is broken in two pieces.Biological matter can be observed over the screw.The overall complaint was confirmed as the observed condition of the 5x12 milagro intererence screw would have contributed to the complained device issue.Based on the investigation findings, the potential root cause is traced to procedural variables, such handling of the device or product interaction during procedure; a guidewire entrapment could have occurred while inserting the screw as per the instructions for use; if resistance occurs during the insertion of a milagro interference screw over a guidewire, stop, and confirm that check for entrapment of the guidewire.If the guidewire is entrapped, back out, remove the screw and withdraw the guidewire.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 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.
Event or Problem Description
It was reported from china that during an arthroscopic cartilage and ligament repair surgery for the right ankle, the unspecified surgical procedure the 5x12 milagro intererence screw device anchor was broken off.All broken parts were removed.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: 5X12 MILAGRO INTERERENCE SCREW
• 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: 20086088
• Report Number: 1221934-2024-03011
• Device Sequence Number: 15406498
• Product Code: MAI
• UDI-Device Identifier: 10886705021963
• UDI-Public: (01)10886705021963(10)201L125(17)260630
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 06/30/2026
• Device Catalogue Number: 231814
• Device Lot Number: 201L125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown