MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATT THEMIS BAL FEM POST RT; SIZING/MEASURING INSTRUMENTS

Catalog Number	254506002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Intraoperatively it was noticed that the two instruments belonging together cannot be connected/assembled.No patient harm reported, no surgical delay reported.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "intraoperatively it was noticed that the two instrument do not fit together as required for balancing.It was not possible to use the balancing; procedure was changed to native mechanical alignment.No patient harm reported, no surgical delay reported.¿ the product was not returned to medtech orthopaedics; however, photos were provided for review.(b)(4).The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.The provided evidence was not sufficient to confirm the reported event of inability to assemble.Functionality issues cannot be evaluated through a photo investigation.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.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 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: based on the information provided by the manufacturing site: 1) quantity manufactured: (b)(4); 2) date of manufacture: 12/1/2022; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: n/a; 5) ifu reference: 0902-60-001.Refer attachment "re: (b)(4).".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, ¿intraoperatively it was noticed that the two instrument do not fit together as required for balancing.It was not possible to use the balancing; procedure was changed to native mechanical alignment.No patient harm reported, no surgical delay reported¿ the product returned to medtech orthopaedics for evaluation.The medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis revealed that att themis bal fem post rt has several signs of deformation around the edges of the post.Additionally, the device presents several brown-orange stains that appears to be evidence of corrosion throughout the entire surface, mainly located on the engravings and the teethed portion of the post.A functional test was preformed with the returned mating device (att themis bal tib tower rt).The assessment revealed that the femoral tensor post was not able to pass thought the entire assembly of the tibial tower as intended, most likely due to the observed condition of the returned devices.The observed condition of the assembly tube is consistent with a random component failure that may have been caused by exposure to unintended forces, heavy use and misalignment of devices during assembly.However, without further information, it is not possible to determine the root cause.Regarding the corrosion, this condition is not an expected failure if it is used as intended and the parameters within the instructions for use (ifu) are followed for cleaning, decontamination and sterilization.The device had experienced 2.9 years of usage and the number of procedures (cycles) it had gone through its life in the field is unknown.Although the observed condition of the instrument cannot be attributed to design or manufacturing, with the information available, a definitive root cause cannot be established at this time due to there being multiple factors that may influence.A manufacturing record evaluation was performed for the finished device [254506002 / cv226606] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the att themis bal fem post rt 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 j&j 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.1) quantity manufactured: 70 2) date of manufacture: 12/1/2022 3) any anomalies or deviations identified in dhr: none 4) expiry date: n/a.5) ifu reference: (b)(4).Device history review a manufacturing record evaluation was performed for the finished device [254506002 / cv226606] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
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.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.

• Brand Name: ATT THEMIS BAL FEM POST RT
• Common Device Name: SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; 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 46581-0988 ; 3035526892
• MDR Report Key: 20310295
• Report Number: 1818910-2024-20238
• Device Sequence Number: 7726778
• Product Code: HWT
• UDI-Device Identifier: 10603295496960
• UDI-Public: (01)10603295496960(10)CV226606
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2024

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: 254506002
• Device Lot Number: CV226606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 12/10/2024; 12/11/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/29/2024; 12/11/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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