MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500504

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(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

Broken attune size 4 articulating surface.Noticed it was broke during case after it went through sterile processing.Product was immediately removed from case.

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: no device was received for examination, but based on the submitted photo this event of breakage could be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 FB PS ARTIC SURF SZ4
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8367063
• MDR Text Key: 137045584
• Report Number: 1818910-2019-85699
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295132448
• UDI-Public: 10603295132448
• Combination Product (y/n): N
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 254500504
• Device Lot Number: MVMBQC330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR