MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US COR/TRI ANT STEM INSERT SHAFT; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	259807440
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the tip of the instrument broke during surgery.The broken fragment entered the patient and was difficult to locate and remove.This may pose risks to the patient.
Event or Problem Description
Additional information received states that the broken fragment has not been left in the patient.The hospital is no longer using the instrument at the moment.
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: b5.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: corrected: h6 - removed patient code: foreign body and pec: functional - foreign body left in patient.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, ¿the tip of the instrument broke during surgery.The hospital has experienced this issue with this instrument before (see attached photo).This occurred during the operation; the broken fragment entered the patient and is sometimes difficult to locate and remove.This may pose risks to the patient.¿ the product was not returned to depuy synthes, however photos were provided for review.See attachment schermafbeelding 2026-02-26 153042.Png.Review of the photographic evidence revealed the shaft without the tip, indicative of breakage.However, the tip was not observed in the provided picture.The fracture is consistent with cyclic bending loading of the inserter tip that exceeded the fatigue strength of the material.Previous investigations based on failure analysis through complaint data, identified that exposure to high-cycle impact loading, particularly when combined with slightly off-center and/or irregular impact patterns, can induce cyclic bending stresses on the inserter tip.These conditions may significantly accelerate the propagation of fatigue cracks, ultimately leading to the mechanical failure of the impactor tip.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the cor/tri ant stem insert shaft 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 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.Added: d9.

• Brand Name: COR/TRI ANT STEM INSERT SHAFT
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24561141
• Report Number: 1818910-2026-04528
• Device Sequence Number: 15668678
• Product Code: HWR
• UDI-Device Identifier: 10603295148425
• UDI-Public: (01)10603295148425(10)PG342870
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Physician
• 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: 259807440
• Device Lot Number: PG342870
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 03/30/2026; 04/02/2026; 05/07/2026; 05/18/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/25/2026; 03/31/2026; 04/03/2026; 05/08/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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