MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN REV ASSEM WRNCH ADAPTOR; ATTUNE STEMMABLE TIBIA INSTRUMENTS : WRENCHES

Catalog Number	254600428
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Tolerence between wrench and implant caused damage to the stem prosthesis.No delay.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The device associated with this report was not returned for evaluation.Photographs and a video were provided for review and confirm the reported event.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUN REV ASSEM WRNCH ADAPTOR
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : WRENCHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7247756
• Report Number: 1818910-2018-52954
• Device Sequence Number: 13649724
• Product Code: HXC
• UDI-Device Identifier: 10603295440307
• UDI-Public: 10603295440307
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/23/2018

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: 254600428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1