MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE DRIVE TIBIA REAMER

Catalog Number	200089
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
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
As reported: damage to the threaded tip of the impact instrumentation for inbone stems.Stems can no longer be fitted and driven in.Replacement was available.
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 shows scratches and blemishes indicative of reusable devices.Significant signs of wear including visible dents and deformation can be seen at the threaded end of the device.The wear is consistent with repeated mechanical stresses exerted during use over an extended period.Based on investigation, the root cause was attributed to a wear related issue.The failure was caused by extensive 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: the useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be re-assessed.
Event or Problem Description
As reported: damage to the threaded tip of the impact instrumentation for inbone stems.Stems can no longer be fitted and driven in.Replacement was available.

• Brand Name: INBONE DRIVE TIBIA REAMER
• Common Device Name: REAMER
• 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: 20156900
• Report Number: 3010667733-2024-00568
• Device Sequence Number: 14512189
• Product Code: HTO
• UDI-Device Identifier: 00840420196187
• UDI-Public: (01)00840420196187(11)200229(10)2229738
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 200089
• Device Lot Number: 2229738
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• 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