MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMP PST AUG TRL 10MM STD+; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	229427051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
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 the items broke.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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 will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COMP PST AUG TRL 10MM STD+
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7326672
• Report Number: 1818910-2018-54821
• Device Sequence Number: 11160810
• Product Code: LXH
• UDI-Device Identifier: 10603295112983
• UDI-Public: 10603295112983
• 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,Followup
• Report Date (Section B): 02/15/2018

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: 229427051
• Device Lot Number: H0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 03/19/2018; 07/03/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 03/20/2018; 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1