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

Catalog Number 254401014

Device Problems Disassembly (1168); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The spring came off the spacer block handle and has not been found.

Manufacturer Narrative

Additional narrative: conclusion and justification status: the complaint states it was reported that there is still an attune set out of action because the spring came off the spacer block handle and has not been found.No product was returned hence the complaint could not be confirmed.A complaints search identified previous complaints received for this failure mode.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; 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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: KNEE INSTRUMENT/TRIAL
• 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: 6578430
• MDR Text Key: 75547153
• Report Number: 1818910-2017-18397
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: 10/05/2017
• Supplement Dates FDA Received: 10/05/2017
• 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