MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE KEEL PUNCH SIZE 3-5; ATTUNE INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET

Catalog Number	254500173
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that once the revision surgery was completed (it¿s reported as (b)(4)).It was reported that the surgeon attempted to check extension and flexion of the patient's knee joint during the revision surgery on (b)(6) 2019 by using the tibial insert trial (p/n: 251700406) with the instruments which were combined with the evaluation bullet no spike (p/n: 254500127) and the keel punch (p/n: 254500173), however the shape of the tibial insert trial did not fit with the instruments and did not engaged.The surgery was completed, and it was unknown whether there was a surgical delay or not.There was no adverse consequence to the patient.No further information is available.
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.Product complaint # (b)(4).No device was returned.Root cause attributed undetermined.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 KEEL PUNCH SIZE 3-5
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8775884
• Report Number: 1818910-2019-97925
• Device Sequence Number: 2521058
• Product Code: LRY
• UDI-Device Identifier: 10603295416036
• UDI-Public: 10603295416036
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 254500173
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1