MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ3; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the complaint; the articulation surface has fractured across the location peg.Heavy gouging was also noted.Examination of the returned device confirmed the reported event.Root cause and corrective action are documented in the capa system.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.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
The instruments were reported for unknown reason.
Additional Manufacturer Narrative
H10 additional narrative: corrected: h6 product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned device identified device damage.Root cause and corrective action are documented in the capa system.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 will be filed as appropriate.

• Brand Name: ATTUNE FB PS ARTIC SURF SZ3
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9884328
• Report Number: 1818910-2020-09340
• Device Sequence Number: 16829507
• Product Code: JWH
• UDI-Device Identifier: 10603295132431
• UDI-Public: 10603295132431
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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 Model Number: 2545-00-503
• Device Catalogue Number: 254500503
• Device Lot Number: MVMBSX240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR