MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE SPACER BLOCK; KNEE INSTRUMENTS

Catalog Number 254401014

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/13/2016

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

Upon inspection of trays, it was found that the spring on the spacer block sz5-6shim side was broken.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint states upon inspection of trays, it was found that the spring on the spacer block sz5-6shim side was broken.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 pra (b)(4) was released on (b)(6) 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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: KNEE INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6200159
• MDR Text Key: 63200767
• Report Number: 1818910-2016-33798
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2016

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: 254401014
• Device Lot Number: BFA0P5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/10/2017; 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2013
• 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