MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 9X30MM; SCREW, FIXATION, BONE

Catalog Number	231822
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 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.H11 additional narrative: photos were returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned photos.Visual analysis of the first photo shows the milagro advance screw 9x30mm attached to the driver, second photo shows the anchor disassembled from the driver, the anchor tip was broken.The overall complaint was confirmed as the observed condition of the milagro advance screw 9x30mm would contribute to the complained device issue.Based on the investigation findings, the potential cause can be attributed to a procedural variables, such handling of the device or product interaction during procedure; resistance may have been felt and an excessive force applied caused the anchor breakage.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.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 reported complaint condition.As part of j&j medtech orthopaedics 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 that during an unspecified surgical procedure the milagro advance screw 9x30mm device anchor the screw broke and got locked in the key, as in photo attached.Another screw of the same size was used to complete the procedure.There was patient involvement.There was no delay to the procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.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 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.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the screw is broken.The broken fragment was not returned.No other anomalies were noted.To test its functionality the anchor was assembled to a test driver no restrictions were noted.Also, the anchor was disassembled as intended.The overall complaint was confirmed as the observed condition of the milagro advance screw 9x30mm would have contributed to the complained device issue.Based on the investigation findings, the potential cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; resistance may have been felt and an excessive force applied caused the anchor breakage.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.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 reported complaint condition.As part of j&j medtech orthopaedics 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.
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.H11 additional narrative: d9, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MILAGRO ADVANCE SCREW 9X30MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 21081152
• Report Number: 1221934-2025-00075
• Device Sequence Number: 8444600
• Product Code: HWC
• UDI-Device Identifier: 10886705022274
• UDI-Public: (01)10886705022274(10)214L025(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2025

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: 08/31/2026
• Device Catalogue Number: 231822
• Device Lot Number: 214L025
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 03/03/2025; 03/04/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/04/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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