MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TRAY TRL W/STEM SZ2.5; KNEE INSTRUMENT : TIBIAL BASE PLATES

Model Number	2294-35-125
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device could not confirm the reported cracked condition.It was found, however, that the tray trial and tray sleeve trial could not be disassembled.The trials were found to be misaligned with each other as a result of suspected improper user technique the investigation did not establish that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Event or Problem Description
Email received from cssd department at (b)(6) hospital with a list of broken instruments.All instruments remain in one piece.Instruments have been received and investigated.

• Brand Name: MBT REV TRAY TRL W/STEM SZ2.5
• Common Device Name: KNEE INSTRUMENT : TIBIAL BASE PLATES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11811661
• Report Number: 1818910-2021-10094
• Device Sequence Number: 3738644
• Product Code: HWT
• UDI-Device Identifier: 10603295113430
• UDI-Public: 10603295113430
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 2294-35-125
• Device Catalogue Number: 229435125
• Device Lot Number: H0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1