MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 7-9MMX30MM TPRSCR; SCREW, FIXATION, BONE

Catalog Number	254624
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from chile while using an unknown implant device that a patient who underwent surgery for chronic ankle instability, who underwent, among other procedures, a reconstruction of the anterior cruciate ligament where the graft was fixed with the milagro advance screw in the femur and tibia with the biointrafix system, was re-operated because 8 years later the biointrafix screw was expelled from the implanted area, causing an infection.The patient underwent surgery again to remove the implant.No additional information was 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.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.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.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.H10 additional narrative: d1, d4, g1-2, h4 : the device brand name, catalog number and manufacture site name and address were documented as unknown in the initial report and have been updated accordingly.The udi has also been updated accordingly.Udi: (b)(4).Investigation summary: according to the information provided, it was reported that patient who underwent surgery for chronic ankle instability, who underwent, among other procedures, a reconstruction of the anterior cruciate ligament where the graft was fixed with the milagro advance screw in the femur and tibia with the biointrafix system, was reoperated because 8 years later the biointrafix screw was expelled from the implanted area, causing an infection.Photos and videos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned images and videos.The images show that the screw was displaced from the implantation site.The image of the device shows that it is covered with biological matter, it does not appear to have any structural abnormalities.The overall complaint was confirmed as the observed condition of the device would contribute to the complained device issue.Based on the investigation findings, there is no indication that the observed device condition would contribute to the complained patient experience.And with the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.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 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.

• Brand Name: BIOINTRAFIX 7-9MMX30MM TPRSCR
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle MA CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18967477
• Report Number: 1221934-2024-00948
• Device Sequence Number: 7938357
• Product Code: HWC
• UDI-Device Identifier: 10886705013210
• UDI-Public: 10886705013210
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K032167
• 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
• Report Date (Section B): 03/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 254624
• 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: 03/17/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown