MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL; HIP INSTRUMENTS: HANDLES

Catalog Number	952211500
Medical Device Problem Codes	Device-Device Incompatibility (2919); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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 report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6: 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.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the overall device surface with signs of usage.Additionally, impaction marks were identified below the head of the device, leaving deformations on its surface.No other cosmetic anomaly was identified.Potential cause for the impaction marks observed can be attributed to unintended use error by improper handling/care of the device that overload the device material; or by impacting the device in unintended places.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed using a broach (201203020) as a depuy synthes sample/mating component.Test revealed the lever loose (before usage) and undesired toggle on the assembly of the device with its mating component, confirming that the device will not hold/retain as intended.Potential cause can be traced to a component failure led by impactions on unintended places; or by excessive force applied while trialing.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.The overall complaint was confirmed as the observed condition of the corail broach handle would have contributed to the complained issue.Based on the investigation findings, 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.
Event or Problem Description
It was reported that the corail broach handle was very loose when holding the modular box osteotome, though it held broaches adequately.The event occurred intra-operatively, with no patient involvement or clinical consequences.

• Brand Name: CORAIL
• Common Device Name: HIP INSTRUMENTS: HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25137878
• Report Number: 1818910-2026-08555
• Device Sequence Number: 15831822
• Product Code: HTQ
• UDI-Device Identifier: 10603295230663
• UDI-Public: (01)10603295230663(10)1816556
• 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

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: 952211500
• Device Lot Number: 1816556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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