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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
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.Udi: (b)(4).Reporter is a j&j sales representative.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, the photo shows the screw with broken condition.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was performed for the finished device lot number: 9l11328, and no nonconformances 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 of the photo, this complaint can be confirmed.The broken anchor can be attributed to procedural variables, such handling of the device or product interaction during procedure, an axial misalignment or bending force was applied to the tip of the device during procedure could cause the broken condition of the screw.However, it cannot be conclusively affirmed.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.
Event or Problem Description
It was reported by the sales rep in sweden that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that the 9x23mm milagro advance interference screw device broke upon insertion.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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: 14876008
• Report Number: 1221934-2022-01959
• Device Sequence Number: 5035374
• Product Code: MAI
• UDI-Device Identifier: 10886705022342
• UDI-Public: 10886705022342
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 02/28/2025
• Device Model Number: 231818
• Device Catalogue Number: 231818
• Device Lot Number: 9L11328
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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