MAUDE Adverse Event Report: DePuy Orthopaedics Inc US ACTIS; Broaches

Catalog Number	201001070
Medical Device Problem Codes	Material Deformation (2976); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > according to the information provided, "it was reported that when setting instruments up the day after case it was noticed that the size 7 actis broach had a large scratch/dent." the product was returned to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual inspection of the returned device found a big deep scratch on one of the sections of the toothed surface.Additionally, the device displays an overall condition consistent with normal and constant usage over time.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, such as, impaction forces with other devices.Properly handling and attention to the approved use of the device diminishes the risk of failure.The reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to unintended use error.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history review = > 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: d3 (manufacturer email), h3.

• Brand Name: ACTIS
• Common Device Name: Broaches
• 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: 50721105
• Report Number: 1818910-2026-15510
• Device Sequence Number: 18278467
• Product Code: HTQ
• UDI-Device Identifier: 10603295393696
• UDI-Public: (01)10603295393696(10)SY164579
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 201001070
• Device Lot Number: SY164579
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• 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