MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 5 LT; FEMORAL TRIALS

Catalog Number 254500715

Device Problems Crack (1135); Scratched Material (3020)

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

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).Investigation summary informed by cssd of cracked or scratched instruments.Part of consigned set, tray and serial number unknown, no patient outcomes, urgent replacement for high volume hospital please.Surgeon unknown- cssd reported.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that attune cr fem trial sz 5 lt was found broken from one of the flange.The broken fragment was returned for evaluation.The cracked and scratched allegation cannot be confirmed.The fracture surface is consistent with overload due to a combination of heavy impaction and the trial fitting too tight over the posterior/anterior aspect of the resected femur bone forcing the curved features of the femoral trial to open.The combination of heavy impaction and possible discrepancies in the resection depth between the femur and the trial suggest unintended user error.Furthermore, per the attune surgical technique (dsus/jrc/0316/1437 rev.K) it is cautioned when extracting the trial, rocking the trial medio-laterally may cause condylar fracture.Such rocking should be avoided a dimensional inspection for the attune cr fem trial sz 5 lt was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune cr fem trial sz 5 lt 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 reported 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 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.

Event Description

It was reported that device is scratched.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? -- no, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? no, 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, (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.

• Brand Name: ATTUNE CR FEM TRIAL SZ 5 LT
• Type of Device: FEMORAL 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 ; 3035526892
• MDR Report Key: 18318709
• MDR Text Key: 330676254
• Report Number: 1818910-2023-25268
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133872
• UDI-Public: 10603295133872
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500715
• Device Lot Number: MVMBBS830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2013
• 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