MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-10-035

Device Problem Difficult to Open or Remove Packaging Material (2922)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patella package ref 1518.10.035 lot 3731917 malfunctioned while opening on to sterile field.

Manufacturer Narrative

Product complaint #
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> pc-(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.H10 additional narrative:  added: b5, d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1, h3.

Event Description

Additional information received indicated that the package failed to open completely across.Causing the sterile product to be trapped inside.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the product was returned to depuy synthes.And sent to depuy ireland manufacturing site for evaluation.Visual examination of the returned sample confirmed, the reported allegation.However, it cannot be traced to a manufacturing issue.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.Drawing/specifications reviewed: n/a.The following drawing/documents were reviewed: n/a.Device history lot: a manufacturing records evaluation was performed.And there was one nonconformance recorded on this batch, that was related to process controls and did not impact on the overall product.

• Brand Name: ATTUNE MEDIAL ANAT PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15157091
• MDR Text Key: 297216978
• Report Number: 1818910-2022-14908
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056638
• UDI-Public: 10603295056638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1518-10-035
• Device Catalogue Number: 151810035
• Device Lot Number: 3731917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• 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