MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE HOLDING TOOL M3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	200364002
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2025
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
It was reported that the holding tool m3 broke off in the tibia tray.A second implant and holding tool was used.
Event or Problem Description
It was reported that the holding tool m3 broke off in the tibia tray.A second implant and holding tool was used.
Additional Manufacturer Narrative
The reported event that could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of returned device confirms the holding tool is broken.The threaded end of the holding tool is broken inside the engaging hole of tibial tray.The fracture pattern of the broken surface suggests brittle fracture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The event was caused by application of higher external forces that contributed to breakage.If any further information is provided, the complaint report will be updated.

• Brand Name: INBONE HOLDING TOOL M3
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 21712190
• Report Number: 3010667733-2025-00376
• Device Sequence Number: 4539853
• Product Code: LXH
• UDI-Device Identifier: 00889797030854
• UDI-Public: (01)00889797030854(11)220920(10)2798597
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 200364002
• Device Lot Number: 2798597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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 Age: 61 YR
• Patient Sex: Male