MAUDE Adverse Event Report: DePuy Orthopaedics Inc US AML EXCEL; Hip Instruments : Handles

Catalog Number	200142000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the excel t-handle devices had wear and tear from multiple uses and the handles were cracked/broken and could not be re-used.It was reported that some devices are cracked at the handle, and two of them are broken in two pieces or more.It was reported that no fragments were generated.There was no patient or user harm reported, and no significant surgical delay.No additional information could be provided.
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.H11: additional manufacturer narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: AML EXCEL
• Common Device Name: Hip Instruments : Handles
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50409279
• Report Number: 1818910-2026-14437
• Device Sequence Number: 9152198
• Product Code: LXH
• UDI-Device Identifier: 10603295079941
• UDI-Public: (01)10603295079941(10)SO2062483
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 200142000
• Device Lot Number: SO2062483
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026; 09/04/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 08/29/2026; 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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