MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE FEM SIZING & FINISH; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Catalog Number 254501703

Device Problems Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that instrument trays were damaged and flaking.

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.

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).Investigation summary: according to the information received.¿it was reported, that instrument trays were damaged and flaking.Hospital is deeming them contaminated for procedures¿.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.It is worth mentioning, that the lid of the instrument case was not returned.Visual analysis of the returned sample revealed, that attune fem sizing & finish has the plastic coating of the brackets peeling off.Causing difficulties, during the sterilization of the case.Additionally, the device presents scratches all over the surface and on the base, where the lot number is located.Consistent with normal an repetitive usage.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.The overall complaint was confirmed.As the observed, condition of the attune fem sizing & finish would contribute to the complained device 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: a manufacturing records evaluation (mre) was not performed, as no lot number was provided and retrieved for this device, due to post manufacturing damage.

• Brand Name: ATTUNE FEM SIZING & FINISH
• Type of Device: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 18920964
• MDR Text Key: 337862488
• Report Number: 1818910-2024-05947
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295423539
• UDI-Public: 10603295423539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254501703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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