MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Model Number 2544-01-004

Device Problems Crack (1135); Material Integrity Problem (2978)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, the patient underwent the surgery via tka.In the surgery, the impactor in question was cracked and damaged while driving the tibial tray.The surgery was completed successfully without any surgical delay.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination found the device chipped and cracked, confirming the reported allegation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: ATTUNE RP TIBIAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16833618
• MDR Text Key: 314199453
• Report Number: 1818910-2023-09093
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130208
• UDI-Public: 10603295130208
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-01-004
• Device Catalogue Number: 254401004
• Device Lot Number: AU3577424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0904-2015
• Patient Sequence Number: 1