MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE TIBIAL DRILL TOWER; ATTUNE INSTRUMENTS : DRILL GUIDES

Catalog Number 254500131

Device Problems Disassembly (1168); Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the drill shaft did not fit into tower properly, producing metal shavings.No surgical delay.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary the instrument associated with this report was not returned.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.

• Brand Name: ATTUNE TIBIAL DRILL TOWER
• Type of Device: ATTUNE INSTRUMENTS : DRILL GUIDES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY SYNTHES; 1210 ward avenue; west chester PA 19380 XXXX
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7468191
• MDR Text Key: 106730507
• Report Number: 1818910-2018-58391
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295130956
• UDI-Public: 10603295130956
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/03/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 254500131
• Device Lot Number: SO2006138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/27/2018
• Date Device Manufactured: 11/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1