MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION BROACH HANDLE; KNEE INSTRUMENTS : HANDLES

Catalog Number	254600418
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lever got jammed of attune femoral imp/extr and the base snapped off from the broach handle.The product damage was identified during loan kit inspection, by the loan kit technician.There is no surgeon, procedure, or patient details available.
Additional Manufacturer Narrative
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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 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.H11 additional narrative: added: d9, g1 (manufacturing site name).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 that "these instruments are composed of 1 part.The lever got jammed of attune femoral imp/extr and the base snapped off from the broach handle.As per the images attached.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available." this complaint involves one (1) device.The product was not returned to medtech orthopedics; however, photos were provided for review.(b)(4).The photo investigation revealed that ¿254600418, attune revision broach handle¿ has broken.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune revision broach handle would contribute to the complained device issue.Based on the investigation findings, attune revision broach handle was broken because of 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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary these instruments are composed of 1 part.The lever got jammed of attune femoral imp/extr and the base snapped off from the broach handle.As per the images attached.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the weld of the attune revision broach handle has fractured causing the base to separate.Additionally, base was found with impaction marks on one side from the bottom.The observed condition can be attributed to a combination of heavy use and unintended impaction forces, likely from bottom-up impactions to disengage the device.Properly handling and attention to the approved use of the device diminishes the risk of failure.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 revision broach handle would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use 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 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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received that "these instruments are composed of 1 part.The lever got jammed of attune femoral imp/extr and the base snapped off from the broach handle.As per the images attached.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available." this complaint involves one (1) device.The product was not returned to medtech orthopedics; however, photos were provided for review.(b)(4).The photo investigation revealed that ¿254600418, attune revision broach handle¿ has broken.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune revision broach handle would contribute to the complained device issue.Based on the investigation findings, attune revision broach handle was broken because of 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 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 REVISION BROACH HANDLE
• Common Device Name: KNEE INSTRUMENTS : HANDLES
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21985668
• Report Number: 1818910-2025-07368
• Device Sequence Number: 4311272
• Product Code: LXH
• UDI-Device Identifier: 10603295475910
• UDI-Public: (01)10603295475910(10)AB4187369
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 254600418
• Device Lot Number: AB4187369
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/02/2025; 06/03/2025; 06/04/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/03/2025; 06/04/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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