MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL VIEW PLT SZ2; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS

Model Number	2178-65-120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary, the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
It was reported that the plastic mbt tibial trial broke in half after removing from on top of broach in the tibia.No delay in surgery, all pieces were recovered.Broke into two pieces, just needs replaced.No surgical delay.

• Brand Name: MBT REV TIBIAL VIEW PLT SZ2
• Common Device Name: KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11263351
• Report Number: 1818910-2021-02219
• Device Sequence Number: 11588832
• Product Code: LXH
• UDI-Device Identifier: 10603295096658
• UDI-Public: 10603295096658
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 2178-65-120
• Device Catalogue Number: 217865120
• Device Lot Number: SO2033397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1