MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC LISFRANC SCREW 4.5 X 50MM CHARLOTTE F AND A SYSTEM; SCREW, FIXATION, BONE

Catalog Number	43504550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device not available.
Event or Problem Description
It was reported that the patient underwent a revision surgery of the right ankle due to painful hardware.Patient has a long history of rigid flatfoot and a valgus degenerative tibiotalar arthritis.
Additional Manufacturer Narrative
The reported event ¿revision¿ could be confirmed, since the information obtained during the investigation indicated a revision surgery had been performed due to pain.The device inspection was not possible as the product was not returned for investigation.However, ct scans, x-rays, and medical records were made available for evaluation.Upon further investigation of the ct scans, x-rays, and medical records by healthcare professionals the following was observed, ¿the provided x-rays and the ct scan show a sequence of ongoing posttraumatic ankle arthrosis.Associated with a highly instable tn-joint and as a consequence of a flat foot deformity.A talonavicular and a talocalcanear joint arthrodesis have been performed successfully.The ankle joint shows significant signs of arthrosis." and "independently from the successfully performed stabilization operations on the foot a joint replacement is planned in the future.The implants do not show signs of failure, loosening or breakage.The irritation of the patient might be caused by the slightly prominent plate".The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient underwent a revision surgery of the right ankle due to painful hardware.Patient has a long history of rigid flatfoot and a valgus degenerative tibiotalar arthritis.

• Brand Name: LISFRANC SCREW 4.5 X 50MM CHARLOTTE F AND A SYSTEM
• Common Device Name: SCREW, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17824153
• Report Number: 3010667733-2023-00560
• Device Sequence Number: 20364671
• Product Code: HWC
• UDI-Device Identifier: 00840420103055
• UDI-Public: 00840420103055
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 43504550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male