MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADV PEEK SCREW 8X30MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	231867
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).The expiration date is unknown at this time.
Event or Problem Description
The surgeon advised that a patient that had an acl reconstruction on the (b)(6) 2017 had recently presented to his clinic with a bulge at the site of the tibial tunnel.The surgeon arranged for the patient to have a scan and it highlighted that the milagro screw had "backed" out of the tunnel.The surgeon requested the patient attend clinic on wednesday the (b)(6) 2020 and under a local anesthetic made an incision and removed the screw.
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.Investigation summary according to the information received, it was reported that the surgeon advised that a patient that had an acl reconstruction on the (b)(6) 2017 had recently presented to his clinic with a bulge at the site of the tibial tunnel.The surgeon arranged for the patient to have a scan and it highlighted that the milagro screw had "backed" out of the tunnel.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the milagro screw had a backout position from the tunnel.A manufacturing record evaluation was performed for the finished device lot number: [l421945], and no non-conformances were identified.As per ifu-114006, the contraindications, an insufficient quantity or quality of bone, comminuted bone surfaces, or pathologic bone conditions such as cystic change or severe osteopenia that would impair the ability of the milagro advance peek interference screw to securely fixate to the bone.The complaint reported was confirmed.The photo do not provide enough evidence to determine root cause.The possible root cause for the reported failure can be attributed to the screw didn't inserted correctly in the bone hole.However, this cannot be conclusive determined.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.The patient identifier was inadvertently missed on the initial report.The patient identified was: ur#(b)(6).

• Brand Name: MILAGRO ADV PEEK SCREW 8X30MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10950711
• Report Number: 1221934-2020-03786
• Device Sequence Number: 16849112
• Product Code: MBI
• UDI-Device Identifier: 10886705026432
• UDI-Public: 10886705026432
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

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 Model Number: 231867
• Device Catalogue Number: 231867
• Device Lot Number: L421945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/09/2021
• Patient Sequence Number: 1