MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB CUT BLCK MOUNT; RESECTION BLOCKS/DEVICES

Catalog Number	250610110
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	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the mount will not lock into place.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint sample consisted of (1) 250610110 attune rev tib cut blck mount, lot ab4206501.Examination of the returned device confirms the attune rev tib cut blck mount will not hold the attune revision tibial block r.The locking mechanism will not tighten onto the cutting block making it unable to hold the cutting block into place.A worldwide complaints database search was performed and found one other complaint ((b)(4)) where the attune rev tib cut blck mount would not hold the tibial cutting block.The root cause is determined to be undetermined.Due to the determination of the root cause no corrective action is being initiated but the complaints will be monitored through (b)(4).Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).
Event or Problem Description
It was reported that the attune rev tib cut blck mount does not tighten onto attune rev tibial block r.

• Brand Name: ATTUNE REV TIB CUT BLCK MOUNT
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8437248
• Report Number: 1818910-2019-87898
• Device Sequence Number: 13522308
• Product Code: HTZ
• UDI-Device Identifier: 10603295436171
• UDI-Public: 10603295436171
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: 250610110
• Device Lot Number: AB4206501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1