MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33600030
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the surgeon was performing a conventional infinity total ankle replacement went that wrong.After initial sizing and checking, the cuts were made.Then the cuts looked different from what we sized so we went back to check the sizing again and then the sizing was completely different from the previous pictures and the cuts were too wrong so we couldn¿t proceed with an infinity procedure.The patient was closed up and a week later they went in for a ankle arthrodesis.
Additional Manufacturer Narrative
Correction d9/h3 product return, h3 reason for no evaluation.The complaint could be confirmed, since the returned image for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: i do not think there is a mismatch between the size of the cutting block and the bone resections.The x-rays are however suggesting that the initial rotation of the first jig was not made in the optimal rotational position, and/or that the tibial cut guide unintendedly guide shifted a bit laterally.The x-rays suggest that unintendedly the lateral cut on the tibial side was made a bit further laterally than usual, ending up in the syndesmotic tibial gutter.This can explain the experienced mismatch between the size of the cutting block and the size of the tibial area that was experienced after bone resection.This seems to be supported by the fact that the cement spacer has no support on the lateral tibial side.The whole-leg x-rays support the above suggestions, looking at the projections of the pin holes, both in the proximal and the distal tibia.See the position of the holes lateral to the mechanical axis in the attached file.To either confirm or reject this hypothesis, a ct-scan to assess the tibial torsion and to assess the exact place of the bone cuts will give the necessary information.No irregularities could be found in relation to any instrument.No irregularities could be found in relation to any implant, as there was no device implanted in this case.No other irregularities could be found.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device not returned.
Event or Problem Description
It was reported that the surgeon was performing a conventional infinity total ankle replacement went that wrong.After initial sizing and checking, the cuts were made.Then the cuts looked different from what we sized so we went back to check the sizing again and then the sizing was completely different from the previous pictures and the cuts were too wrong so we couldn't proceed with an infinity procedure.The patient was closed up and a week later they went in for a ankle arthrodesis.

• Brand Name: INFINITY¿ 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14337006
• Report Number: 3010667733-2022-00178
• Device Sequence Number: 17452261
• Product Code: HSN
• UDI-Device Identifier: 00889797004008
• UDI-Public: 00889797004008
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K123954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: Health Professional
• Device Model Number: 33600030
• Device Catalogue Number: 33600030
• Device Lot Number: 2488554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown