MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FEMORAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Catalog Number 254401006

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the investigation confirmed the reported event.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.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 impactor was broken, found during clean up and did not impact case.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: the investigation confirmed the reported event.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.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 IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7185507
• MDR Text Key: 97070866
• Report Number: 1818910-2018-51047
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130222
• UDI-Public: 10603295130222
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401006
• Device Lot Number: AU4790476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• 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