MAUDE Adverse Event Report: DePuy Mitek LLC US GII QUICKANCHOR ORTHOCORD; Staple, Fixation, Bone

Catalog Number	222983
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury

• Brand Name: GII 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: 50918239
• Report Number: 1221934-2026-04383
• Device Sequence Number: 5394690
• Product Code: JDR
• UDI-Device Identifier: 10886705008612
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K041115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• 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: 222983
• Device Lot Number: 10CPU2
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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 Age: 40 YR
• Patient Sex: Female