MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE FEMORAL IMPACTOR; TRIAL INSTRUMENT

Catalog Number 254401006

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

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.Expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune femoral impactor has been annealed to reduce residual stresses.Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable.The annealed product was released on 30-jul-2014.This device is from an un-annealed batch.A field safety notice was issued in nov 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor¿s to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.Device history lot
=
> null.Device history review
=
> null.

Event Description

It was reported that when the surgeon impacted the femur, the femur impactor split down the middle and broken into 2 pieces.

Manufacturer Narrative

(b)(4).Investigation summary
=
> the investigation confirmed that the impactor is cracked.Expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune femoral impactor has been annealed to reduce residual stresses.Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable.The annealed product was released on (b)(6) 2014.This device is from an un-annealed batch.A field safety notice was issued in nov 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor¿s to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the investigation confirmed that the impactor is cracked.Expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune femoral impactor has been annealed to reduce residual stresses.Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable.The annealed product was released on (b)(6) 2014.This device is from an un-annealed batch.A field safety notice was issued in (b)(6) 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor¿s to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.

• Brand Name: ATTUNE FEMORAL IMPACTOR
• Type of Device: TRIAL 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: 7120698
• MDR Text Key: 95064599
• Report Number: 1818910-2017-51760
• 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,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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: AU3207741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2013
• 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: 55 YR