MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TIBIAL TRAY IMPACT ARM UNIVER INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680143
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the: "impactor arm broke during implant impaction, leaving a broken metal shard in the patient.Surgeon had to do extra incision to remove it.It was removed from the patient.The surgery continued as planned and the outcome expected was received.There was harm to the patient, there was an extra hour to the tourniquet time and an extra unplanned incision had to be made to retrieve it.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the: "impactor arm broke during implant impaction, leaving a broken metal shard in the patient.Surgeon had to do extra incision to remove it.It was removed from the patient.The surgery continued as planned and the outcome expected was received.There was harm to the patient ¿ there was an extra hour to the tourniquet time and an extra unplanned incision had to be made to retrieve it.".
Additional Manufacturer Narrative
Correction to 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 confirms the catalog and lot number.Scratches and blemishes consistent with reusable instruments can be seen around the device.A metal component of the impaction mechanism is visibly detached at the slotted region on the posterior side of the device.The broken off fragment was not returned for evaluation.Based on investigation, the root cause was attributed to a wear related issue.The failure was most likely caused by excessive use of the device over a prolonged period of time.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 instructions for use were reviewed and states: surgical instruments and instrument cases are susceptible to damage from prolonged use and through misuse or rough handling.Care must be taken to avoid compromising their exacting performance.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: TIBIAL TRAY IMPACT ARM UNIVER 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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22078117
• Report Number: 3010667733-2025-00645
• Device Sequence Number: 8702111
• Product Code: HSN
• UDI-Device Identifier: 00889797102339
• UDI-Public: (01)00889797102339(11)221007(10)2772284
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33680143
• Device Lot Number: 2772284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown