MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE FB TIB BASE SZ 5 POR; KNEE IMPLANT - TIBIAL TRAY

Catalog Number	150621005
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that when the item was opened (box reads sz 5 affixium 1506-21-005) lot??? the sticker inside box reads sz 6 (1506-21-006) lot ja06a0954.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that item opened (box reads sz 5 affixium 1506-21-005) sticker inside box reads sz 6 (1506-21-006) lot ja06a0954.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the label corresponding to size 6 was mistakenly placed on the package of the attune fb tib base sz 5 por.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 5 por would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.However, a nr has been initiated to address the current complaint issue.

• Brand Name: ATTUNE FB TIB BASE SZ 5 POR
• Common Device Name: KNEE IMPLANT - TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19043188
• Report Number: 1818910-2024-07087
• Device Sequence Number: 15571168
• Product Code: MBH
• UDI-Device Identifier: 10603295507420
• UDI-Public: 10603295507420
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2024

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 Catalogue Number: 150621005
• Device Lot Number: JA05A1115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 06/21/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/17/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown