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

Catalog Number 254401003

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

During impaction of the tibial tray, the attune fb tibial impactor split into two pieces.

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Conclusion and justification status: the complaint states during impaction of the tibial tray the attune fb tibial impactor split into two pieces and surgeon discarded it onto the floor.Rep did not notice any evidence of cracking or wear prior to impactor breaking.Unfortunately the hospital has thrown out the broken impactor so it is not available for return.Patient stable on table post surgery.No delay to procedure.No adverse event.The investigation confirmed that the impactor had broken as reported with the photo provided.Expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune fb tibial 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.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.It should be noted that (b)(4) has been initiated and can be referenced for further details.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 FB TIBIAL 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: 4840392
• MDR Text Key: 5874838
• Report Number: 1818910-2015-23391
• 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: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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: Health Professional
• Device Catalogue Number: 254401003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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