MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP PS ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-545

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Naturally Worn (2988)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

It was reported that the depuy attune psrp artic surf insert trial spring on post was damaged and worn.Almost completely ripped off.All pieces were retrieved.No surgical delay.

Manufacturer Narrative

(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.

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) upon further review, it has been determined that the instrument was not broken into 2+ pieces.It has been determined the spring was deformed, fell apart - attached.Depuy synthes joint reconstruction does not consider this failure to be a reportable malfunction at this time.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: ATTUNE RP PS ARTIC SURF SZ5
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• 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: 15276471
• MDR Text Key: 303236606
• Report Number: 1818910-2022-16416
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295132851
• UDI-Public: 10603295132851
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-545
• Device Catalogue Number: 254500545
• Device Lot Number: MVMCJH290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2014
• 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-2139-2015
• Patient Sequence Number: 1
• Patient Sex: Female