MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ3 10MM; TIBIAL INSERT TRIALS

Catalog Number 254500916

Device Problem Crack (1135)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was reported that the shim is cracked.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 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 cracked shim, in need of urgent replacement.No patient outcomes, surgeon unknown- cssd reported.Part of consigned set, tray and serial number unknown.Tagged as damaged and in loan tub ready for collection.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the device did not found evidence of crack reported allegation.However examination of the returned device revealed chipped from the edges.The failure mode is consistent with using the device in a prying motion to disassemble the mating instruments after trialing resulting in material overload.No material or manufacturing defects were observed that would have contributed to the fracture.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test cannot be performed due to the condition of the complaint.The overall complaint was unconfirmed as the observed condition of the attune conv shim sz3 10mm would not have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended user error, and it has been determined that no corrective and/or preventative action is proposed.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 CONV SHIM SZ3 10MM
• Type of Device: TIBIAL INSERT 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: 18595810
• MDR Text Key: 335076415
• Report Number: 1818910-2024-01898
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295134930
• UDI-Public: 10603295134930
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500916
• Device Lot Number: BFA1KNG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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