MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIBIAL DRILL TOWER; ATTUNE INSTRUMENTS : DRILL GUIDES

Model Number 2545-00-131

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 on (b)(6) 2023, during the tka surgery, the patella tendon pulled on the tibial coarse surface bone fragments, causing an avulsion fracture.It was happened when the surgeon fixed the tibial tray since the knee was heavily contracted with tka size 7.The reason is that the design of the instrument is not excellent when installing the product in question, making it difficult for the tower to be installed.The surgery was completed within 30 minutes delay.The surgeon commented that the device is too bulky and the tibial tray fixation pin is not embedded, making it inoperable.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.The reported allegation can be confirmed, however the visual examination found nothing indicative of a device nonconformance.The overall appearance of the device is used.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE TIBIAL DRILL TOWER
• Type of Device: ATTUNE INSTRUMENTS : DRILL GUIDES
• 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: 16663249
• MDR Text Key: 312508190
• Report Number: 1818910-2023-07144
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295130956
• UDI-Public: 10603295130956
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2545-00-131
• Device Catalogue Number: 254500131
• Device Lot Number: SO2018764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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
• Patient Outcome(s): Required Intervention