MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION SYSTEM HANDLE; HANDLES

Model Number	2546-00-100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Instrument's trigger handle was found to be broken upon routine check of the instrumentation by the regional manager for form/fit/function.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device could not confirm the reported event of device breakage, but could confirm device stiffness.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE REVISION SYSTEM HANDLE
• Common Device Name: HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10613293
• Report Number: 1818910-2020-21356
• Device Sequence Number: 457854
• Product Code: LXH
• UDI-Device Identifier: 10603295438731
• UDI-Public: 10603295438731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 2546-00-100
• Device Catalogue Number: 254600100
• Device Lot Number: AB4187354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1