MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	220222904
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient at this time.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient had a fall where the patient sustained a medial malleolus fracture which is unrelated to the specific implant.The reason the physician is revising the case is due to a worry for implant loosening.The surgeon originally planned to explant the device and repair the fracture but the patient wanted it done in two stages.
Event or Problem Description
It was reported that the patient had a fall where the patient sustained a medial malleolus fracture which is unrelated to the specific implant.The reason the physician is revising the case is due to a worry for implant loosening.The surgeon originally planned to explant the device and repair the fracture but the patient wanted it done in two stages.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.Based on investigation, the root cause was attributed to a patient related issue.As the revision was caused, as reported, to a fall where the patient sustained a medial malleolus fracture and is unrelated to the specific implant.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INBONE¿ TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13283115
• Report Number: 3010667733-2022-00024
• Device Sequence Number: 4944691
• Product Code: HSN
• UDI-Device Identifier: 00840420124289
• UDI-Public: 00840420124289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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 Model Number: 220222904
• Device Catalogue Number: 220222904
• Device Lot Number: 1699797
• 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: 12/21/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male