MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC STRAIGHT TUBULAR PLATE 6 HOLE ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Catalog Number	58880106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient requires a revision surgery due to a medial malleolus fracture that is not healing and lucency under the tibial implant.Both sides are being revised.The surgery was completed and all components were explanted and a cement spacer was placed.The patient underwent an ankle fusion.
Additional Manufacturer Narrative
Correction to g1(reporting contact).The reported event could be confirmed since images of ct scans were provided and shows the presence of a medial malleolus fracture and loosening of the tibial component.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned.However, an image of the explanted plate was provided.Multiple scratches, most likely resulting from the explantation process can be seen on the plate.For further evaluation, the device will need to be returned.Upon further investigation of the ct scans by healthcare professionals the following was observed: the ct quality provided is poor.The described medial malleolus fracture, however, can be confirmed.There is also the hypertrophic pseudarthrosis visible.The implant may have impingement with the malleolus as well.The tibial radiolucency indicates loosening.The failure could be patient related due to poor bone substance, but also procedure related as there is the bone contact with the medial malleolus.Although the issue is most likely both patient and procedure related, the root cause could not be conclusively determined.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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
The digital stryker prophecy team received a ct scan indicating that the patient requires a revision surgery due to a medial malleolus fracture that is not healing and lucency under the tibial implant.Both sides are being revised.The surgery was completed and all components were explanted and a cement spacer was placed.The patient underwent an ankle fusion.

• Brand Name: STRAIGHT TUBULAR PLATE 6 HOLE 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: 21712796
• Report Number: 3010667733-2025-00378
• Device Sequence Number: 21350069
• Product Code: HRS
• UDI-Device Identifier: 00889797067140
• UDI-Public: 00889797067140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 58880106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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: 61 YR
• Patient Sex: Male