MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-10-032

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/01/2021

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

Scratch on implant.No surgical delay.No patient consequence.

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 could not confirm the reported event.No evidence was found indicating product error was a contributing factor depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : a review was completed of the device history record (dhr) and operations management system (oms) for the following: product code 151810032, work order (b)(4) was manufactured on 26 apr 2021.(b)(4) parts were manufactured to specification.There was no scrap associated with this lot.There were no non-conformances associated with this lot.There were no deviations associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.

• Brand Name: ATTUNE MEDIAL ANAT PAT 32MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12095865
• MDR Text Key: 259275973
• Report Number: 1818910-2021-14050
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056621
• UDI-Public: 10603295056621
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1518-10-032
• Device Catalogue Number: 151810032
• Device Lot Number: 9771804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1