MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REV CONV CUT GUIDE SZ 7; RESECTION BLOCKS/DEVICES

Catalog Number	250440607
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Re-open upon receipt of the device evaluation of the returned device finds the posterior saw slot is bent.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
A decision was made to utilise the attune revision system.During the course of the procedure the conventional femoral cutting block was utilised.This was positioned and pinned in place.When attempting to make the posterior chamfer cut through the saw slot, it was found that the saw blade could not fit through the slot.The slot was then checked with the angle wing and it was found that this also, did not fit through the posterior chamfer slot.This had a short delay in the surgery and required the posterior chamfer be respected freehand.This is a new attune revision knee set, so this would be the first time this instrument has been utilised.
Additional 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.  added: device code.Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Re-open upon receipt of the device evaluation of the returned device finds the posterior saw slot is bent.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ATTUNE REV CONV CUT GUIDE SZ 7
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8261872
• Report Number: 1818910-2019-81473
• Device Sequence Number: 1947542
• Product Code: HTZ
• UDI-Device Identifier: 10603295438465
• UDI-Public: 10603295438465
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 250440607
• Device Lot Number: ABG43592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1
• Patient Age: 72 YR