MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTSCR 9X30MM *EA; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	231825
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
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.The complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.Since the complaint device was implanted, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device, and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported by the sales rep in india that during an anterior cruciate ligament (acl) surgical procedure on (b)(6) 2024 while using the cortical fxation fxd loop 20mm device and the milagro intscr 9x30mm *ea on femur side the surgery went well and the patient was discharged.After two to three months the patient showed sign on infection at the operated site and took advice from other surgeon, who after checking the patient reported and implants commented to the patient about sub standard implants used.The patient has filed compliant against operative surgeon doctor of north star multispecialty hospital kolhapur.Hospital has requested from company a quality certificate to further endorsed clinically proven implants were used in the surgery.There was no delay in the procedure reported.No additional information was provided.This is report 2 of 2 of the same events.

• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 20124690
• Report Number: 1221934-2024-03031
• Device Sequence Number: 14240944
• Product Code: MAI
• UDI-Device Identifier: 10886705010806
• UDI-Public: (01)10886705010806(10)143L656(17)260228
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150209
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 231825
• Device Lot Number: 143L656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown