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

Catalog Number 254401014

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Event Description

Attune spacer block discovered broken in spd.

Manufacturer Narrative

Additional narrative: conclusion and justification status: the complaint states attune spacer block discovered broken in spd.The investigation confirmed the failure mode as reported.The device was reviewed by bioengineering and a report was received stating; investigation of the returned device confirms the complaint; the post of the attune spacer block has broken off.It should be noted that not all pieces have been returned, however the original complaint form states all pieces were removed from the patient.As there are a number of potential root causes that may result in this damage; the cause of the failure is unknown.Design review (b)(4) was completed in august 2016 which investigated possible design solutions to balseal post cracking.It was concluded that no design improvements, protective measures or information for safety could be implemented that would definitely reduce the risks without increasing or adding risks.The q1 2016 pms report ((b)(4)) identifies no safety signals and concludes no follow up actions are required for the attune spacer block.The complaint shall be closed with an undetermined 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).

• Brand Name: ATTUNE SPACER BLOCK
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6124897
• MDR Text Key: 60794454
• Report Number: 1818910-2016-32120
• Device Sequence Number: 1
• Product Code: HWT
• 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: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401014
• Device Lot Number: BFA0P43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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