MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE ATTACH SCREW M3 LONG SIZE 3 AND 4 POLY TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	200329102
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that attachment screw, long, m3 (200329102) broke inside the tibial tray (200252904) almost immediately once the surgeon had started to advance the poly insert.Both the tibial tray and poly insert were damaged in this case.Therefore, we had to use another tibial tray and poly implant and re-implant.Another attachment screw used to implant the poly insert.To implant a new tibial tray, we needed to remove the talar dome and talar stem.We were able to re-assemble the talar dome and use the new implant.This incident caused a 45 minute delay in the procedure.The case was completed successfully with a new tibial tray and poly insert.Power tools was not used and no extra torque was applied by surgeon.
Additional Manufacturer Narrative
Correction - d3 legal manufacturer.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that attachment screw, long, m3 (200329102) broke inside the tibial tray (200252904) almost immediately once the surgeon had started to advance the poly insert.Both the tibial tray and poly insert were damaged in this case.Therefore, we had to use another tibial tray and poly implant and re-implant.Another attachment screw used to implant the poly insert.To implant a new tibial tray, we needed to remove the talar dome and talar stem.We were able to re-assemble the talar dome and use the new implant.This incident caused a 45 minute delay in the procedure.The case was completed successfully with a new tibial tray and poly insert.Power tools was not used and no extra torque was applied by surgeon.

• Brand Name: INBONE ATTACH SCREW M3 LONG SIZE 3 AND 4 POLY TOOL
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20445281
• Report Number: 3010667733-2024-00746
• Device Sequence Number: 8091269
• Product Code: LXH
• UDI-Device Identifier: 00889797030731
• UDI-Public: 00889797030731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 200329102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male