MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL VIEW PLT SZ6

Catalog Number	217865160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Instrument was found broken in the instrument set during the beginning of the case.Not used in surgery but need to be replaced.
Additional Manufacturer Narrative
Additional narrative:  product complaint # = > pc-(b)(4).Investigation summary = > examination of the submitted device confirmed the reported breakage.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > null device history batch = > null device history review = > null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: MBT REV TIBIAL VIEW PLT SZ6
• Common Device Name: TIBIAL VIEW PLT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7107625
• Report Number: 1818910-2017-51257
• Device Sequence Number: 1211044
• Product Code: LXH
• UDI-Device Identifier: 10603295096702
• UDI-Public: 10603295096702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2017

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: 217865160
• Device Lot Number: SO2014927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/10/2018; 03/14/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/22/2018; 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR