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

Catalog Number 254600428

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Tolerence between wrench and implant caused damage to the stem prosthesis.No delay.

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
• Type of Device: ATTUNE STEMMABLE TIBIA INSTRUMENTS : WRENCHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380 ; 6103142063
• MDR Report Key: 7247756
• MDR Text Key: 99229276
• Report Number: 1818910-2018-52954
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295440307
• UDI-Public: 10603295440307
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254600428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1