MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-107

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

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 Description

Intraoperatively after opening the sterile package a scratch was seen on the implant.Another implant was available.No surgical delay, no adverse patient consequences.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: examination of the returned device confirmed the reported event.No definitive evidence was found of product malfunction or product error was identified.The need for corrective action is not established at this time.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: this review identified the following: product code 150410107, work order 9486016 was manufactured on 10th april 2020.12 parts were manufactured per specification and all raw materials met specification.Non-conformances: nr-0143999/nr-0145435 o nr-0143999 relates to a datum block which failed calibration, and therefore no correlation to this complaint description.O nr-0145435 relates to a datum block which failed calibration, and therefore no correlation to this complaint description.There were no scrap parts found to be associated with work order 9486016.There was no reprocessing associated with work order 9486016 corrected: h3.

• Brand Name: ATTUNE PS FEM LT SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10560265
• MDR Text Key: 207731204
• Report Number: 1818910-2020-20529
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041641
• UDI-Public: 10603295041641
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 1504-10-107
• Device Catalogue Number: 150410107
• Device Lot Number: 9486016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 02/19/2021
• Supplement Dates FDA Received: 10/24/2020; 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1