MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TAPERSCR 8-10X30MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	254603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2025
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 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.Device was used for treatment, not diagnosis.H11: additional narrative: e1: the reporter¿s complete facility address was not provided.Investigation summary¿ the complaint device is not being returned; the availability of the device is unknown, therefore unavailable for a physical evaluation.Since the complaint device was not returned, 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.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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
This is report 2 of 3 for (b)(4).It was reported through a review of new zealand acl registry depuy implant report received as per dua-sports-2024-017 contract milestone deliverable that postoperatively to an anterior cruciate ligament procedure on an unknown date, it was observed that the intrafix tibialsheath 30mm device, intrafix taperscr 8-10x30mm device and truespan 0 degree peek device failed and the patient required a re-operation or revision surgery.The status of the patient was unknown.No additional information was provided.A copy of this report is to this medwatch report.

• Brand Name: INTRAFIX TAPERSCR 8-10X30MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 22610561
• Report Number: 1221934-2025-02802
• Device Sequence Number: 13162780
• Product Code: MBI
• UDI-Device Identifier: 10886705013098
• UDI-Public: (01)10886705013098(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 254603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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