MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ5 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680005
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: the tibial tray does not seat on inserter.A new implant was opened.".
Event or Problem Description
As reported: the tibial tray does not seat on inserter.A new implant was opened.".
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: the tibial tray implant was returned for evaluation.Visual examination of the returned device confirms the catalog and lot number.No visible signs of deformation that would impair the functionality of the implant were found.A tibial tray impaction insert was obtained from the kitting team and used to perform the functional test.The tibial tray impaction insert was unable to be assembled properly with the implant as the insert could not fit into the dovetail slot of the implant.Measurements were taken with a digital caliper and found to be within dimensional specifications.The slot of the implant was also found to be within dimensional accuracy after verifying with a gage pin.Quality assurance engineering performed measurements on the implant and confirmed all dimensions conform to specifications.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.R&d reviewed the received information and noted the following: "based on our discussions on the following points: 1-tibial tray insert (instrument) there were no visible issues detected during the functional test.2-the (3) tibial tray implants used during the functional test also met dimensional specifications.3-the actual tibial tray insert used in the surgery was not returned.4- a second tibial tray implant was able to be used successfully with the tibial tray insert (instrument) used during the actual surgical procedure.My evaluation on what is causing this malalignment is inclusive.I recommend keeping this issue on the pms radar so that if it does happen again, we can get back all the offending parts inhouse for deeper evaluations & examinations." the root cause of the issue could not be conclusively determined.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: the tibial tray does not seat on inserter.A new implant was opened.
Additional Manufacturer Narrative
After a thorough review of the risk management file, it has been determined that this record does not meet the criteria for reportability under our current guidelines.Furthermore, it has been noted that this does not suggest that a recurrence of this event would result in a serious injury or death.Additionally, upon review of complaint history, it has been noted that there are no reports of serious injury or death as a result of similar events with this device.Therefore, this complaint and mfr report # 3010667733-2023-00583 will be closed and cancelled.If further information becomes available that suggests otherwise, the reporting decision will be reevaluated.

• Brand Name: INFINITY ADAPTIS TIB SZ5 INFINITY ADAPTIS
• 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17861492
• Report Number: 3010667733-2023-00583
• Device Sequence Number: 17575215
• Product Code: HSN
• UDI-Device Identifier: 00889797069670
• UDI-Public: 00889797069670
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

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: 33680005
• Device Lot Number: 1760814
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 05/21/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 01/18/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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
• Patient Sex: Unknown