MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV P-F STEM TRL 12X60; STEM TRIALS

Catalog Number	251312060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.
Event or Problem Description
It was reported that the stem trial fractured at the threaded junction of the part during removal of the broach in the tibia on a sawbone.A sales representative, who was undergoing training through the attune revision training demonstration, observed the failure while completing the task.It was confirmed that the stem trial was the old design, which was released with the early launches of the attune revision knee system (prior to the stem trials being optimized for use with broaching).It should be noted that the stem trial diameter, in relation to the tibial canal, was intentionally undersized during the demonstration.The under-sizing of the stem trial, could have led to the part being further off-axis in relation to the line of impaction, therefore increasing the overall stress on the threaded junction if it were to be slightly loose from the mating interface (broach).The part was retrieved from the sawbone.No patient interaction as it occurred during a training demonstration.

• Brand Name: ATTUNE REV P-F STEM TRL 12X60
• Common Device Name: STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7868061
• Report Number: 1818910-2018-69068
• Device Sequence Number: 1964064
• Product Code: LXH
• UDI-Device Identifier: 10603295438809
• UDI-Public: 10603295438809
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 251312060
• Device Lot Number: NW192247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1