MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP PST AUG TRL 10MM MED; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	229427031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 trial augment broken off.The set was a back up and not needed.It was used during the case.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COMP PST AUG TRL 10MM MED
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7556266
• Report Number: 1818910-2018-60934
• Device Sequence Number: 16619181
• Product Code: LXH
• UDI-Device Identifier: 10603295112945
• UDI-Public: 10603295112945
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/03/2018

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: 229427031
• Device Lot Number: BF0709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1