MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 1S; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number	G4260101
Medical Device Problem Codes	Break (1069); Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stubbed their toe 3 months post-op causing the implant to fail, degrading and breaking laterally.The patient underwent a revision surgery 5 months post-op.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned implant shows the implant is broken off at the midsection.Significant wear and deformation can be seen around the midsection of the implant.Upon further investigation of the radiographic images by healthcare professionals the following was observed: ¿there is a radiograph and some photos of the implant available, which confirm the failure of the implant.The use of a grommet is recommended in patients with rheumatoid arthritis or in those with higher activity levels.We can see, that the failure occurred exactly at the site of the implant where the grommet is foreseen to save the implant and to reduce peak load levels.¿ based on investigation, the root cause was attributed to a patient related issue.As reported by the sales rep, the implant failure occurred when the patient stubbed their toe, resulting in the breakage.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.The instructions for use were reviewed and states: "the swanson flexible hinge toe joint grommet is a thin titanium shield designed for use with the swanson flexible hinge toe implant in rheumatoid patients where cutting or abrasion of the flexible implant from contact with thin, sharp bone edges can occur, or in patients who have high activity levels.It is contoured to conform to the shape of the midsection of the flexible implant and is fabricated from unalloyed titanium for surgical application.The distal grommet is used on the distal stem and the proximal grommet is used on the proximal stem to protect the implant from biomechanical shearing forces of sharp bone edges during joint motion." no indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient stubbed their toe 3 months post-op causing the implant to fail, degrading and breaking laterally.The patient underwent a revision surgery 5 months post-op.

• Brand Name: FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS 1S
• Common Device Name: PROSTHESIS, TOE, CONSTRAINED, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19093329
• Report Number: 3010667733-2024-00203
• Device Sequence Number: 20684731
• Product Code: KWH
• UDI-Device Identifier: 00840420127464
• UDI-Public: 00840420127464
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K780132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: G4260101
• Device Lot Number: 1755474
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2023
• 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: 63 YR
• Patient Sex: Female