MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM TRIAL SZ 6 LT; FEMORAL TRIALS

Catalog Number 254500736

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).H6:part/ component/ sub assembly term not applicable (g07001) investigation summary
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> it was reported that there was crack in the trial close to the catalog number.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found attune ps fem trial sz 6 lt had a cracked on the middle of device, confirming allegation.Additionally, scratches, from saw blade excursion, were found on external surface; and an unknown substance on inner surface of device.Crack 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.Potential cause for scratch condition can be traced to unintended use error, as condition can be consistent with other tools and hard edges coming in contact with the device.Properly handling and attention to the approved use of the device diminishes the risk of failure.Potential cause for the unknown foreign substance condition can be traced to maintenance as device shows evidence of this condition after being sterilized.A dimensional inspection and a functional test were not performed since it were not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune ps fem trial sz 6 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 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.

Event Description

It was reported that there was crack in the trial close to the catalog number.Additionally, scratches, from saw blade excursion, were found on external surface; and an unknown substance on inner surface of device.

• Brand Name: ATTUNE PS FEM TRIAL SZ 6 LT
• Type of Device: 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18948733
• MDR Text Key: 338229061
• Report Number: 1818910-2024-06219
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295134084
• UDI-Public: 10603295134084
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500736
• Device Lot Number: MVMCBH940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2014
• 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