MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV CONV&OFFST FEM PREP; INSTRUMENT CASES

Model Number	2549-00-070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirmed the reported event.The coating on the brackets was delaminating.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
Event or Problem Description
It was reported that during post cleaning inspection the pan was found to be damaged.The plastic holder for the shims was broken off.No surgical delay.

• Brand Name: ATTUNE REV CONV&OFFST FEM PREP
• Common Device Name: INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10537755
• Report Number: 1818910-2020-20114
• Device Sequence Number: 2670053
• Product Code: FSM
• UDI-Device Identifier: 10603295476016
• UDI-Public: 10603295476016
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/24/2020

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: 2549-00-070
• Device Catalogue Number: 254900070
• Device Lot Number: PV0156626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1