MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DISTAL FEMORAL JIG; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number	254400520
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent an unknown surgery with the product in question.The product was used on (b)(6) and the surgery was completed successfully with no surgical delay.After the surgery, while sorting instruments for the next operation, a wire-like part on the outrigger slide was found to be protruding outward, despite its inherent design not being exposed.This protrusion is not seen on normal products.This product was not used during the operation on monday, september 1st, and the same product at another facility was used instead.
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).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: d9.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: it was reported that on (b)(6) 2025, the patient underwent an unknown surgery with the product in question.The product was used on friday, on (b)(6) at 2:00 pm.The surgery was completed successfully with no surgical delay.After the surgery on friday at 6:00 pm while sorting instruments for the next operation (monday, on (b)(6), a wire-like part on the outrigger slide was found to be protruding outward, despite its inherent design not being exposed.This protrusion is not seen on normal products.This product was not used during the operation on monday, on (b)(6) and the same product at another facility was used instead.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the attune distal femoral jig had the main body missing.Only the slide tube assembly was returned.Additionally, the slide tube spring has come apart from its original position.This condition could be consistent with a random component failure that may have been caused by exposure to unintended forces like excessive force while assembling or disassembling from the mating device or heavy usage.However due to the low frequency of this occurrences and not suspecting any design issue, a definitive root cause cannot be established.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune distal femoral jig would have contributed to a device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that on (b)(6) 2025, the patient underwent an unknown surgery with the product in question.The product was used on friday, (b)(6) at 2:00 pm.The surgery was completed successfully with no surgical delay.After the surgery on friday at 6:00 pm while sorting instruments for the next operation (monday, (b)(6), a wire-like part on the outrigger slide was found to be protruding outward, despite its inherent design not being exposed.This protrusion is not seen on normal products.This product was not used during the operation on monday, (b)(6), and the same product at another facility was used instead.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the attune distal femoral jig had the main body missing.Only the slide tube assembly was returned.Additionally, the slide tube spring has come apart from its original position.This condition could be consistent with a random component failure that may have been caused by exposure to unintended forces like excessive force while assembling or disassembling from the mating device or heavy usage.However due to the low frequency of this occurrences and not suspecting any design issue, a definitive root cause cannot be established.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune distal femoral jig would have contributed to a device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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.Corrected: h3.

• Brand Name: ATTUNE DISTAL FEMORAL JIG
• Common Device Name: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23075298
• Report Number: 1818910-2025-16042
• Device Sequence Number: 17340042
• Product Code: HWT
• UDI-Device Identifier: 10603295434030
• UDI-Public: (01)10603295434030(10)AB5116171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 254400520
• Device Lot Number: AB5116171
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 11/25/2025; 01/23/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/19/2025; 11/26/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• 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