MAUDE Adverse Event Report: DEPUY MITEK LLC US 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231818
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2022
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Additional narrative: udi: (b)(4).Reporter is a j&j employee.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.
Event or Problem Description
It was reported by the affiliate in colombia that during an unknown surgery on 6/14/2022, it was observed that the 9x23mm milagro advance interference screw device broke.According to the report, while inserting the nitinol guide, the screw was placed in the femoral tunnel, leaving the nitinol guide trapped.It was reported that when trying to remove trapped nitinol guide, the screw was moved back a few millimeters, then advanced but the coil on the device broke into three fragments before finishing.All fragments were recovered which caused an hour delay in the procedure.A double-row anchor was used to complement the fixation of the graft in the femur.There were no adverse patient consequences nor surgical delay reported.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.If information is obtained that was not available for the initial medwatch, a folow-up medwatch will be filed as appropriate.H10 additional narrative: additional information b5: upon further investigation additional information has been received.The affiliate reported that a competitor's guide device that was in the institution was used due to a back order situation.It was reported that the guide was also broken during screw insertion.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: the complaint device was received and evaluated.Upon visual inspection, two pieces of the broken screw were returned.A manufacturing record evaluation was performed for the finished device 8l75630 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause can be attributed 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 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.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Brand Name: 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• 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: 14857724
• Report Number: 1221934-2022-01935
• Device Sequence Number: 5195979
• Product Code: MAI
• UDI-Device Identifier: 10886705022342
• UDI-Public: 10886705022342
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup,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: 10/31/2024
• Device Model Number: 231818
• Device Catalogue Number: 231818
• Device Lot Number: 8L75630
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 08/17/2022; 08/31/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 06/30/2022; 08/18/2022; 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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