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

Catalog Number	254500736
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during loan kit inspection it was noted the femoral trial insert has damage to the outer face near the top.There is no procedure or patient involved.
Additional Manufacturer Narrative
(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 the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: according to the information received, "femoral trial insert has damage to the outer face near the top." the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that attune ps fem trial sz 6 lt ,the photographs attached were reviewed, however in the images provided no observations pertaining to the nature of the reported event could be identified.The photo investigation reveals that the device is scratch.This type of damage is consistent with the device coming in contact with the saw blade while trialing, care should be taken to avoid saw blade excursion into the femoral trials or implants.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not 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, potential cause attributed to unintended user error and 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 complaint condition.As part of medtech orthopaedics 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.H11 additional narrative: added: h4.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information received, "femoral trial insert has damage to the outer face near the top." the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment (254500736.Jpeg & 254500736 2of2.Jpeg).The photo investigation revealed that attune ps fem trial sz 6 lt, the photographs attached were reviewed, however in the images provided no observations pertaining to the nature of the reported event could be identified.The photo investigation reveals that the device is scratch.This type of damage is consistent with the device coming in contact with the saw blade while trialing, care should be taken to avoid saw blade excursion into the femoral trials or implants.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not 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, potential cause attributed to unintended user error and 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 complaint condition.As part of medtech orthopaedics 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.

• Brand Name: ATTUNE PS FEM TRIAL SZ 6 LT
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21926097
• Report Number: 1818910-2025-06623
• Device Sequence Number: 8650638
• Product Code: HWT
• UDI-Device Identifier: 10603295134084
• UDI-Public: (01)10603295134084(10)MVMFVL260
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 254500736
• Device Lot Number: MVMFVL260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 06/11/2025; 06/19/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/04/2025; 06/12/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown