MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 6 CEM; KNEE TIBIAL TRAY

Model Number 1506-70-006

Device Problems Incomplete or Missing Packaging (2312); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

The implant box was opened and the plastic box containing the second, sterile plastic box was removed from the box.The white paper on the top on the plastic box containing the sterile content was peeled back to expose the sterile content.When the paper was peeled back, it was noted a sticker containing black arrow to lift the internal sterile content of the box was not present.This made the removal of the internal sterile box difficult.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FB TIB BASE SZ 6 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13804490
• MDR Text Key: 288189151
• Report Number: 1818910-2022-04914
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295492085
• UDI-Public: 10603295492085
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K170806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

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
• Device Operator: Health Professional
• Device Model Number: 1506-70-006
• Device Catalogue Number: 150670006
• Device Lot Number: 9695298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/18/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1