MAUDE Adverse Event Report: DePuy Mitek LLC US MICROFIX QUICKANCHOR ORTHOCORD; STAPLE, FIXATION, BONE

Catalog Number	212045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Purulent Discharge (1812)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Postoperative purulent discharge & suture rejection.It was reported that the patient underwent surgery in (b)(6) 2024 to implant the device.After surgery, the patient exhibited purulent discharge, and the suture was rejected from the root of nail.The suture appears white to the naked eye.The surgeon stated that it could not be confirmed whether the discharge suture was the implanted device in previous surgery.The patient underwent surgery to remove some of the discharge suture last year.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.

• Brand Name: MICROFIX QUICKANCHOR ORTHOCORD
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): DePuy Mitek LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50059369
• Report Number: 1221934-2026-03319
• Device Sequence Number: 9349773
• Product Code: HTY
• UDI-Device Identifier: 10886705001903
• UDI-Public: (01)10886705001903(10)169L178(17)incomplete
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup,Followup

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 212045
• Device Lot Number: 169L178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 07/31/2026; 08/13/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 07/31/2026; 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• 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