MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS

Catalog Number 254401014

Device Problems Component Missing (2306); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

It was reported that the patient had a right total attune knee.During reassembly of the instruments, it was noticed that a retaining spring from an insert trial was missing and one was missing from the spacer block.The instrument room told me the springs were sprung and fell off these instruments so they discarded the springs.No pieces were left in the patient.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: examination of the returned device revealed the locking mechanism is missing.The investigation could not identify a root cause for the missing balseal spring without the spring component to examine.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 9172055
• MDR Text Key: 186791409
• Report Number: 1818910-2019-108734
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295395379
• UDI-Public: 10603295395379
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• 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: BFA109C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR