MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE FEMORAL INTRODUCER; KNEE INSTRUMENT

Catalog Number 254401005

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary
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> conclusion and justification status: the complaint states it was reported that the femoral introducer's red screw was broke.All pieces found.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 (b)(4) in accordance with the post market surveillance plant dva-107550-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 (b)(4).

Event Description

It was reported that the femoral introducer's red screw was broke.All pieces found.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
=
> conclusion and justification status: the complaint states it was reported that the femoral introducer's red screw was broke.All pieces found.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 (b)(4).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 (b)(4) in accordance with the post market surveillance plant (b)(4).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).Device history lot
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> null device history lot
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> null device history review
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> null.

• Brand Name: ATTUNE FEMORAL INTRODUCER
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• 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: 7099436
• MDR Text Key: 94409724
• Report Number: 1818910-2017-51032
• 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
• Report Date: 11/10/2017

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: Health Professional
• Device Catalogue Number: 254401005
• Device Lot Number: ABD02453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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
• Patient Age: 42 YR
• Patient Weight: 156