MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 8 CEM; KNEE FEMORAL

Model Number	1504-40-108
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
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
It was reported that the white overlapping tab on the inner packaging had been sealed through the outer white covering, thereby compromising the sterile packaging.This would not allow the inner packaging to be removed by the sterile nurse.The inner white cover was peeled back with the inner packaging still within the outer packaging as this was the only way to remove the implant.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.The photographs were review, and it was found that the flange on the inner wrap, containing the sterile product, was overstepping between the outer package and itself, making more difficult the opening process.However that should not compromise the sterility of the product,   depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 CRS FEMORAL LT SZ 8 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12514008
• Report Number: 1818910-2021-20799
• Device Sequence Number: 3913395
• Product Code: JWH
• UDI-Device Identifier: 10603295042211
• UDI-Public: 10603295042211
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 09/01/2021

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: 1504-40-108
• Device Catalogue Number: 150440108
• Device Lot Number: J2211M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1