MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MBT REV TIBIAL VIEW PLT SZ3; KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS

Catalog Number	217865130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Examination of the returned device revealed breakage into two pieces.Ted 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.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
It was reported that the instrument was cracked.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : examination of the returned device revelaed breakage into two pieces.Ted 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.

• Brand Name: MBT REV TIBIAL VIEW PLT SZ3
• Common Device Name: KNEE INSTRUMENT : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8270351
• Report Number: 1818910-2019-81925
• Device Sequence Number: 16568766
• Product Code: LXH
• UDI-Device Identifier: 10603295096672
• UDI-Public: 10603295096672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 01/02/2019

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: 217865130
• Device Lot Number: SO2029776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/04/2019
• Patient Sequence Number: 1