MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 COMP FEM AUG BTN STD+/LG+15DTL; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	217860086
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
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 an augment trial broke and gold knob broke off notch block and both need to be replaced.No surgical delay.
Additional Manufacturer Narrative
Investigation summary the device associated with this report was not returned for evaluation.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Depuy considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: COMP FEM AUG BTN STD+/LG+15DTL
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7264272
• Report Number: 1818910-2018-53263
• Device Sequence Number: 13909216
• Product Code: LXH
• UDI-Device Identifier: 10603295095835
• UDI-Public: 10603295095835
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/29/2018

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: 217860086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 02/12/2018
• 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
• Patient Age: 60 YR