MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION SYSTEM HANDLE; HANDLES

Catalog Number	254600100
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/29/2019
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.Device is an instrument and is not implanted/explanted.
Event or Problem Description
It was reported that the attune revision 29mm sleeve broach got stuck in the tibia.Both broach handle kept releasing on extraction.The small end of the extractor rod was inserted into the broach and a crossbar was put through that to extract the sleeve.Trying to get the rod out of the broach and the tip broke off inside.The 37mm broach was inserted next and it got stuck also.Both broach handles kept releasing.With the extraction rod broken the surgeon screwed the trial rp base plate onto the broach.Tried extracting the whole construct with the system handle and the box adapter.The system handle kept releasing also.It eventually was able to be worked out with this construct.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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: ATTUNE REVISION SYSTEM HANDLE
• Common Device Name: HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8349611
• Report Number: 1818910-2019-84930
• Device Sequence Number: 13941753
• Product Code: LXH
• UDI-Device Identifier: 10603295438731
• UDI-Public: 10603295438731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 254600100
• Device Lot Number: AB3747021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1