MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TRIAL POLY INSERT SZ 2 6MM INFINITY TOTAL ANKLE SYSTEM; TEMPLATE

Model Number	33622206
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
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 inserter broke during use.No additional information was provided.
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: visual examination of the returned device confirms the device is broken off into two pieces.The nature of the fracture surface exhibits signs of a brittle fracture.Based on investigation, the root cause was attributed to a user related issue.The failure was most likely caused by a combination of rough handling and excessive usage of the device over multiple reprocessing cycles.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.The current instructions for use states: "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling." no indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the inserter broke during use.No additional information was provided.

• Brand Name: TRIAL POLY INSERT SZ 2 6MM INFINITY TOTAL ANKLE SYSTEM
• Common Device Name: TEMPLATE
• 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: 16800213
• Report Number: 3010667733-2023-00212
• Device Sequence Number: 3140034
• Product Code: HWT
• UDI-Device Identifier: 00889797006620
• UDI-Public: 00889797006620
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 33622206
• Device Catalogue Number: 33622206
• Device Lot Number: 2485802
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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
• Patient Sex: Unknown