MAUDE Adverse Event Report: DEPUY IRELAND 961610 ATTUN REV PST F AUGTRL 8XSZ3-4; FEMORAL TRIALS

Catalog Number	254903002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
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
Trial shows magnetic/metal wear before use.Instrument was wiped before it underwent thermal disinfection at local bq site.After thermal disinfection it showed up like seen on photos.2nd photos show the metal wear after it was wiped again.Given ref/lot is only an example - wear appears on all magnetic augments.
Additional Manufacturer Narrative
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
Trial shows magnetic/metal wear before use.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).No device was received for examination, therefore the reported event could not 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUN REV PST F AUGTRL 8XSZ3-4
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• MDR Report Key: 7813908
• Report Number: 1818910-2018-67660
• Device Sequence Number: 1535996
• Product Code: HRY
• UDI-Device Identifier: 10603295439295
• UDI-Public: 10603295439295
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/20/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 254903002
• Device Lot Number: NW198491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 12/20/2017; 08/24/2018; 11/16/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 08/24/2018; 08/30/2018; 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1