MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS #2S; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Model Number	G4260102
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the swanson implant box was opened, two proximal grommets in package.
Additional Manufacturer Narrative
Correction d9/h3, h6 method code; the reported event could be confirmed, since the device was returned with the proximal grommet missing and two distal grommets found instead in the packaging.Based on investigation, the root cause was attributed to a manufacturing related issue.The failure was caused by improper handling/packaging of device.The current instructions for use 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." a nonconformance was opened into this issue to further investigate the problem.
Event or Problem Description
It was reported that the swanson implant box was opened, two proximal grommets in package.

• Brand Name: FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS #2S
• 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: 14160654
• Report Number: 3010667733-2022-00164
• Device Sequence Number: 4961273
• Product Code: KWH
• UDI-Device Identifier: 00840420127471
• UDI-Public: 00840420127471
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K780132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G4260102
• Device Catalogue Number: G4260102
• Device Lot Number: 1717547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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
• Patient Sex: Unknown