MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC 3DI CROSSCHECK MTP LEFT ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Catalog Number	5820MPX1L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ortholoc crosscheck plate broke sometime after the initial surgery was completed resulting in a non-union.The patient was brought back, and the surgeon had to remove the plate and replaced it.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the ortholoc crosscheck plate broke sometime after the initial surgery was completed resulting in a non-union.The patient was brought back, and the surgeon had to remove the plate and replaced it.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the visual examination of the received product shows that the plate is broken apart through the locking hole at the most proximal and lateral end of the plate.The plate is showing scratches all over the surface as well some deformation and discoloration, but afterwards it cannot be defined if these damages were caused during insertion or extraction.The microscopic examination of the fracture surface shows that the fracture characteristics indicate a fatigue fracture.The reported lack of bone healing certainly played a role in this case.All measurement taken are within accuracy.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a use related issue.The failure was caused most likely in combination of the non-union and due to weight bearing.If more information is provided, the case will be reassessed.

• Brand Name: 3DI CROSSCHECK MTP LEFT ORTHOLOC 3DI PLATING SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23318723
• Report Number: 3010667733-2025-01185
• Device Sequence Number: 4989298
• Product Code: HRS
• UDI-Device Identifier: 00840420187031
• UDI-Public: (01)00840420187031(11)230517(10)1758762
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: Lay User/Patient
• Device Catalogue Number: 5820MPX1L
• Device Lot Number: 1758762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 97 KG