MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL BLOCK R; RESECTION BLOCKS/DEVICES

Model Number	2506-10-112
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
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
It was reported that the drill pin got stuck in revision attune tibial block right side.The disposal pin is stuck in the block and the packaging for the disposal pin was discarded.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with the reported event was not returned, however, review of the provided photo confirmed the reported event.Furthermore, the fixation pin appeared bent and twisted consistent with suspected off axis alignment of the mating pin under power resulting in the pin and block fusing together.Based on the observation of the investigation, the need for corrective action is not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: lot information not available.

• Brand Name: ATTUNE REVISION TIBIAL BLOCK R
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12166555
• Report Number: 1818910-2021-15158
• Device Sequence Number: 11712611
• Product Code: HTZ
• UDI-Device Identifier: 10603295436232
• UDI-Public: 10603295436232
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 2506-10-112
• Device Catalogue Number: 250610112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 95