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

Catalog Number 254401003

Device Problem Material Integrity Problem (2978)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that the impactor was damaged.Patient status/ outcome / consequences: no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.): no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study: unknown, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of:none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: informed by cssd of damaged instruments, tagged as damaged and ready for collection.Part of consigned set, tray and serial number unknown.No patient outcomes.Surgeon unknown- cssd reported.The device associated with this report was returned to depuy synthes for evaluation.¿visual inspection of the returned sample revealed that the attune fb tibial impactor was found broken in two parts from the middle.No other issues were observed.The broken fragment was returned for examination.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune fb tibial impactor would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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.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.

• Brand Name: ATTUNE FB TIBIAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• 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 ; 3035526892
• MDR Report Key: 18552203
• MDR Text Key: 333356730
• Report Number: 1818910-2024-01508
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130192
• UDI-Public: 10603295130192
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254401003
• Device Lot Number: AU58826161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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