MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CR FEM TRIAL SZ 3 LT; FEMORAL TRIALS

Catalog Number	254500713
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported the femoral cr trial - lug drill got stuck, melted off plastic.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, femoral cr trial - lug drill got stuck, melted off plastic.The product was not returned to medtech orthopaedics, however photos were provided for review.See attachment image (3).Jpg.The photo investigation revealed that '( 254500713 ,attune cr fem trial sz 3 lt) had broken."the potential cause is traced to repeated impaction forces during trialing in combination with the trial fitting very tightly posteriorly/anteriorly over the resected femur bone.This will cause tensile stress initiating at the bone contact surface in the middle of the trial between the condyles, resulting in material fatigue and ultimately cracking.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 provided evidence was not sufficient to confirm the reported event of jammed/ seized fell apart unattached.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (attune cr fem trial sz 3 lt) would contribute to the complained device issue.Based on the investigation findings, end of life problem 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.
Event or Problem Description
Additional information was received and states that: was there any fragments generated? yes.Were they removed from patient? yes.How was the procedure completed? yes.Was there any surgical delay? no.Was there any patient consequences reported? no.
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 that 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.H11 additional narrative: added: b5, h6 health effect (clinical and impact code).If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > according to the information received, femoral cr trial - lug drill got stuck, melted off plastic.The product was not returned to medtech orthopedics, however photos were provided for review.See attachment image (3).Jpg.The photo investigation revealed that '( 254500713 ,attune cr fem trial sz 3 lt) had broken.The potential cause is traced to repeated impaction forces during trialing in combination with the trial fitting very tightly posteriorly/anteriorly over the resected femur bone.This will cause tensile stress initiating at the bone contact surface in the middle of the trial between the condyles, resulting in material fatigue and ultimately cracking.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 provided evidence was not sufficient to confirm the reported event of jammed/ seized.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (attune cr fem trial sz 3 lt) would contribute to the complained device issue.Based on the investigation findings, end of life problem 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 orthopedics 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: g1 (manufacturing site name).
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 hat 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.H11 additional narrative: added: d9.Corrected: h3.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 cr trial - lug drill got stuck, melted off plastic.The product was not returned to medtech orthopedics, however photos were provided for review.The photo investigation revealed that '(254500713, attune cr fem trial sz 3 lt) had broken."the potential cause is traced to repeated impaction forces during trialing in combination with the trial fitting very tightly posteriorly/anteriorly over the resected femur bone.This will cause tensile stress initiating at the bone contact surface in the middle of the trial between the condyles, resulting in material fatigue and ultimately cracking.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 provided evidence was not sufficient to confirm the reported event of jammed/ seized.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was (confirmed) as the observed condition of the (attune cr fem trial sz 3 lt) would contribute to the complained device issue.Based on the investigation findings, end of life problem 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 orthopedics 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 CR FEM TRIAL SZ 3 LT
• Common Device Name: 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: 21457577
• Report Number: 1818910-2025-03013
• Device Sequence Number: 20730748
• Product Code: HWT
• UDI-Device Identifier: 10603295133858
• UDI-Public: (01)10603295133858(10)MVMBGZ080
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 254500713
• Device Lot Number: MVMBGZ080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/03/2025; 03/10/2025; 04/01/2025; 05/19/2025; 06/04/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/04/2025; 03/11/2025; 04/02/2025; 05/20/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2021
• 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