MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500506

Device Problems Break (1069); Device-Device Incompatibility (2919)

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

Event Date 01/12/2024

Event Type  malfunction  

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 Description

Within the procedure, the surgeon removes the trial insert, fb ps tibia trial insert size 6, from the patient who breaks a part of it.The surgery was uneventful, there were no inconveniences or delays and the surgery was accomplished successfully and smoothly.The doctor no longer required the test.There was no impact on the patient and the broken part of the piece remains together with the marked piece inside the instruments.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, within the procedure, the surgeon removes the trial insert, fb ps tibia trial insert size 6, from the patient who breaks a part of it.The surgery was uneventful, there were no inconveniences or delays and the surgery was accomplished successfully and smoothly.The doctor no longer required the test.There was no impact on the patient and the broken part of the piece remains together with the marked piece inside the instruments.The product was not returned to depuy synthes, however photos were provided for review.See attachment source file - reporte de calidad clinica farallones colectivo 452802.The photo investigation revealed that attune fb ps artic surf sz6 is broken from one of the post components.This condition can also be related to the unable to disassemble condition reported as it can't be correctly used if the device is broken.It is also observed that the spring from the broken post is deformed.No other issues were found.This failure mode is consistent with inserting an extractor device in between the trial and mating shim, and using the extractor to pry the mating devices apart during extraction of the trials.This improper technique results in damage to the spring and/or post components of the articulating surface.The attune intuition surgical technique 0612-10-512, emphasizes the correct use of the tibial trial extractor (product code 254500138) with the trials.Furthermore, per ifu-0902-00-836, careful inspection of the trials for damage/breakage should be performed pre and post-operative.If any damage to the balseal components is observed the trail should be replaced.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 ps artic surf sz6 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: ATTUNE FB PS ARTIC SURF SZ6
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18542633
• MDR Text Key: 333234627
• Report Number: 1818910-2024-01377
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295132462
• UDI-Public: 10603295132462
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500506
• Device Lot Number: MVMHJS130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male