MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE EVERLAST SZ 2 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	22022208
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during an inbone tar revision surgery, the selected replacement poly did not fit the insertion device , despite being undamaged and unused.A second poly was opened, fit properly, and was successfully implanted.The incident caused an approximate 10-minute surgical delay, with no adverse consequences reported.
Event or Problem Description
It was reported that during an inbone tar revision surgery, the selected replacement poly did not fit the insertion device , despite being undamaged and unused.A second poly was opened, fit properly, and was successfully implanted.The incident caused an approximate 10-minute surgical delay, with no adverse consequences reported.
Additional Manufacturer Narrative
Correction to d4(gtin), g1(reporting contact) and h3(device evaluated by mfg).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 device shows slight deformation on one side of the dovetail section of the poly implant.During functional testing, an attempt was made to assemble the poly implant with a size 2 poly inserter.However, the poly implant could only fit halfway into the inserter.The dovetail section of the poly implant could not slide past the dovetail slot on the inserter.The same issue was noted when attempting to assemble the poly implant with a different inserter.A measurement was taken of the bottom width dovetail section of the poly implant with a digital caliper.The measurement indicated the width exceeded the specified tolerance.Following the inspection with the digital caliper, quality assurance engineering performed an inspection of the poly implant using a cmm machine and noted that the width exceeded the specified tolerance by 0.0008 in.Quality assurance engineering noted the following: during the investigation, it was determined that the width was out of specification by.0008 in.One side of the dovetail appears to be damaged.Therefore, we requested all the inspection data from the supplier.The inspection data was reviewed and found to be within specification at the time of manufacture.I believe one side of the insert was damaged during insertion of the implant into the instrument.Additionally, a sales history was provided indicating a total of 15 units from the affected lot were sold between 2022 and 2025 with no other complaints reported for this lot to date.Based on investigation, the root cause was attributed to a user related issue.As noted by quality assurance engineering, the failure was most likely caused by damage incurred on one side of the dovetail section of the poly implant during an attempt to assemble the implant with the inserter.The supplier's inspection data confirmed the implant met specifications at the time of manufacture suggesting the damage occurred post production.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 more information is provided, the case will be reassessed.

• Brand Name: INBONE EVERLAST SZ 2 8MM 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20605939
• Report Number: 3010667733-2024-00820
• Device Sequence Number: 15494886
• Product Code: HSN
• UDI-Device Identifier: 00889797074865
• UDI-Public: (01)00889797074865(11)221020(17)301020(10)1726721
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 Catalogue Number: 22022208
• Device Lot Number: 1726721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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 Age: 62 YR
• Patient Sex: Female