MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM TRIAL SZ 7 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-737

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that there are black spots all over device.

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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.However, photos were provided for review.Review of the provided photos revealed, that the trails had signs of black spots on the surface.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : black spots all over.The device associated with this report was returned to depuy synthes for evaluation.Cleaning/sterilization protocols were asked, however they were not provided.Visual analysis of the returned sample revealed that attune ps fem trial sz 7 lt confirmed the presence of black particles firmly adhered to the surface of the device.From the observations made of the previous investigation (b)(4), (b)(4) as well as from the similar physical observations made of the current complaint sample, the black particle contamination is considered not related to material or manufacturing defects.The overall complaint was confirmed as the observed condition of the attune ps fem trial sz 7 lt would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to maintenance process.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 manufacturing records evaluation (mre) was not performed.H3.

• Brand Name: ATTUNE PS FEM TRIAL SZ 7 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17071574
• MDR Text Key: 316606044
• Report Number: 1818910-2023-11674
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295134091
• UDI-Public: 10603295134091
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140881
• 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,Followup,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-737
• Device Catalogue Number: 254500737
• Device Lot Number: MVMBWZ200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• 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