MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PFCSIG INS TRL STABL 8MM SZ2.5; KNEE INSTRUMENT : TIBIAL TRIALS

Catalog Number	961430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
It was reported that 2.5 x 8, 10 mm insert trials broke.Lip that sits in tray on both.All pieces retrieved.Surgery not delayed.Trials thrown away by cpd.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the device associated with this report was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIG INS TRL STABL 8MM SZ2.5
• Common Device Name: KNEE INSTRUMENT : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7362170
• Report Number: 1818910-2018-55889
• Device Sequence Number: 11081053
• Product Code: LXH
• UDI-Device Identifier: 10603295238232
• UDI-Public: 10603295238232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 961430
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1