MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC LOCKING SCREW 3.5 X 28MM ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Catalog Number	58803528
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery is needed due to talus component screws¿ breakage.The existing tibia component will remain in situ.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since images of ct scans were provided and shows breakage of the screws.Upon further investigation of the ct scans by healthcare professionals the following was observed: breakage of the screws could be confirmed.Poor bone substance and sequential collapse of the central bone support below the component have contributed to the screw breakage.Based on investigation, the root cause of the screw breakage was attributed to a patient related issue.As noted by a medical professional, the failure was caused by poor bone substance and sequential collapse of the central bone support below the component.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a revision surgery is needed due to talus component screws¿ breakage.The existing tibia component will remain in situ.

• Brand Name: LOCKING SCREW 3.5 X 28MM 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21577592
• Report Number: 3010667733-2025-00325
• Device Sequence Number: 8940017
• Product Code: HRS
• UDI-Device Identifier: 00840420113153
• UDI-Public: 00840420113153
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K102429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 58803528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/21/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 98 KG