MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REV NOTCH GUIDE SZ3; FEMORAL TRIALS

Catalog Number	250440403
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
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
"rust" type residue on attune revision size 3 notch cutting block.Reported by fremantle cssd department who refused to sterilise the instrument patient status/ outcome / consequences --> no.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.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 REV NOTCH GUIDE SZ3
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8469038
• Report Number: 1818910-2019-89127
• Device Sequence Number: 16589462
• Product Code: HTZ
• UDI-Device Identifier: 10603295438014
• UDI-Public: 10603295438014
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 250440403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1