MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE POLY SZ 2+ 10MM SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220223210E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that when inserting the poly at the end of the case, the poly got damaged upon insertion.We had a second poly to insert and it too had a small damaged when inserting on the latter side but the surgeons was ok to use it.A surgical delay of approximately 15 minutes was encountered.
Event or Problem Description
It was reported that when inserting the poly at the end of the case, the poly got damaged upon insertion.We had a second poly to insert and it too had a small damaged when inserting on the latter side but the surgeons was ok to use it.A surgical delay of approximately 15 minutes was encountered.
Additional Manufacturer Narrative
The reported event could be confirmed, since evaluation of the returned device does find damage/deformation to the dovetail feature.Examination of the returned poly confirms the catalog and lot and finds one of the posterior corners is deformed/damaged that is consistent with an attempted insertion with force.Due to the damage/deformation, certain specifications were unable to be confirmed.Other key dimensions were taken and found to be within specifications.The surgical technique does note to slide the poly insertion tool assembly over the attachment screw and align flush with the anterior surface of the tibial tray.Thread the attachment nut onto the attachment screw to lock the poly insertion tool to the tibial tray.It also states to prevent incomplete seating of the poly insert, properly irrigate the tibial tray prior to poly insertion.Apply slight reaction force as necessary to keep insertion tool at 90 degrees to tibia.Available stock did confirm that no other units were available for evaluation.It was also noted that no other similar complaints for this particular lot have been reported.Based on the details obtained during the investigation, the root cause was attributed to a user related issue.The event was likely caused by incomplete seating and/or alignment of the poly into the tibial tray resulting in the deformation/damage and inability to insert the poly.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 POLY SZ 2+ 10MM SULCUS
• 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: 19735690
• Report Number: 3010667733-2024-00438
• Device Sequence Number: 20584512
• Product Code: HSN
• UDI-Device Identifier: 00840420125019
• UDI-Public: (01)00840420125019(11)220606(17)300606(10)1719300
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 220223210E
• Device Lot Number: 1719300
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2022
• 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 Sex: Female