MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSIGMA DIST FEMAUG TRL8MM S3; FEMORAL TRIALS

Catalog Number	961862
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
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
Found broken in sterile processing.
Additional Manufacturer Narrative
(b)(4).The device associated with the reported event was not returned for examination.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIGMA DIST FEMAUG TRL8MM S3
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7399090
• Report Number: 1818910-2018-56759
• Device Sequence Number: 16475164
• Product Code: LXH
• UDI-Device Identifier: 10603295240327
• UDI-Public: 10603295240327
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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): 03/06/2018

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: 961862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1