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

Model Number	200364002
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2023
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 on a supplemental report.
Event or Problem Description
It was reported that during an inbone prophecy procedure the end of the holding tool snapped off inside the sz4 tibial tray.Since the holding tool snapped off inside the tibial tray the physician could not attach the poly inserter, the physician has to insert the poly by hand but could not sear it properly.It was 2mm proud when the operation was completed.
Event or Problem Description
It was reported that during an inbone prophecy procedure the end of the holding tool snapped off inside the sz4 tibial tray.Since the holding tool snapped off inside the tibial tray the physician could not attach the poly inserter, the physician has to insert the poly by hand but could not sear it properly.It was 2mm proud when the operation was completed.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Upon further investigation of provided information by healthcare professional and r&d the following was observed- "with the limited information and without any additional imaging it is difficult to say anything to this, but pe is expected to place correctly on the implant when the patient puts weight on it, otherwise with a false conjunction between the components the likelihood of wear or loosening of the component is very high.Also, from r&d of view ¿the holding tool is made of implantable material (cocr) and so the risk is low for the implant containing a piece of the tool ¿ 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.If device is returned or any further information is provided, the investigation report will be reassessed.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16584724
• Report Number: 3010667733-2023-00137
• Device Sequence Number: 17374834
• Product Code: LXH
• UDI-Device Identifier: 00889797030854
• UDI-Public: 00889797030854
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/12/2023

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: 200364002
• Device Catalogue Number: 200364002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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