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

Catalog Number 254401006

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

Conclusion and justification status: the complaint states the attune femoral impactor cracked.The investigation confirmed that the impactor had broken 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.

Event Description

The attune femoral impactor cracked.Upon evaluation of the returned impactor ((b)(4)) it was found to be broken, not cracked as originally reported.(b)(4).

• Brand Name: ATTUNE FEMORAL IMPACTOR
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4997369
• MDR Text Key: 22822600
• Report Number: 1818910-2015-27768
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Report Date: 07/28/2015

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: 254401006
• Device Lot Number: AU3357853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1