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

Catalog Number 254401014

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

Conclusion and justification status: the complaint states balseal of attune spacer block has failed.The spring is damaged but remains intact and damage to the post was also noted per the photo provided.The investigation confirmed the failure mode as reported.Care needs to be used when assembling these connections, as damage may occur resulting in the type of failure seen here.However, there is insufficient information supplied with this complaint to determine whether sufficient care was or was not taken.It should be noted that (b)(4) was released on 08 jul 2014 in which the damage to the balseals was evaluated.The pra concluded that there is no patient harm as none of the failure modes have led to any patient harm.Furthermore, the assembly and disassembly of this device is carried out by the scrub nurse on a table away from the joint space, additionally the device cannot be disassembled within the joint space.It should also be noted that this issue will be further monitored in post market surveillance.The complaint shall be closed with an undetermined conclusion and entered into the complaints system and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.(b)(4).

Event Description

Balseal of attune spacer block has failed.The spring is damaged but remains intact and damage to the post was also noted per the photo provided.**update sep 15, 2015** upon evaluation of the returned (254401014/bfa0rp6), one of the 4 posts was found to be broken, and one balseal damaged.

• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5080175
• MDR Text Key: 25900787
• Report Number: 1818910-2015-30699
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• 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: BFA0RP6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• 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