MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEMORAL INTRODUCER; ATTUNE INSTRUMENTS : INSERTION DEVICES

Catalog Number 254401005

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 femoral introducer broke during impaction.No surgical delay.Patient was not affected.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: conclusion and justification status: the complaint states it was reported that the femoral introducer broke during impaction.No surgical delay.Patient was not affected.The device was reviewed and confirmed the failure mode as reported.Investigation into this failure mode has indicated that the root cause is associated with fatigue of the ml slide screw either side of the cross pin, where the cross sectional area was the smallest.This failure mode has been adequately assessed within the risk management for the instrument (dva-105445-fde).The issue will continue to be monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Continued post market surveillance will be carried out per sep (b)(4) in accordance with the post market surveillance plant dva(b)(4) pmsp.The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FEMORAL INTRODUCER
• Type of Device: ATTUNE INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7185698
• MDR Text Key: 97084400
• Report Number: 1818910-2018-51068
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295130215
• UDI-Public: 10603295130215
• 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,Followup
• Report Date: 12/19/2017

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: No Information
• Device Catalogue Number: 254401005
• Device Lot Number: ABC70103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/15/2018; 08/30/2018
• Supplement Dates FDA Received: 01/16/2018; 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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