MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL AMT NECK SEG 135D STD; FEMORAL TRIALS

Catalog Number	L94005
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2024
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.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.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 (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.
Event or Problem Description
It was reported, that on (b)(6) 2024.The patient, underwent the surgery via bha, for femoral neck fracture, for the hip joint with the broach corail neck segment and the broach corail.During surgery, when placing the neck trial, it was harder than usual and uncomfortable to place.After the surgery, it was cleaned and checked.And although, it was inserted smoothly, the feeling of placement was rough.There may have been some foreign object in the neck trial or there may have been a scratch on the male side of the rasp.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > it was reported that on jun.14, 2024, the patient underwent the surgery via bha for femoral neck fracture for the hip joint with the broach corail neck segment and the broach corail.During surgery, when placing the neck trial, it was harder than usual and uncomfortable to place.After the surgery, it was cleaned and checked, and although it was inserted smoothly, the feeling of placement was rough.There may have been some foreign object in the neck trial, or there may have been a scratch on the male side of the rasp.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.The product was returned to depuy synthes for evaluation.Visual inspection revealed scratches on the inner surface of the corail amt neck seg 135d std.No additional damage was observed on the device surface.This type of damage is consistent with other tools and hard/uneven edges coming in contact with the device.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 the corail amt neck seg 135d std as mating device and the broach corail amt 15 as mating component.The functional test revealed that broach corail amt 15 was able to assemble but with a certain difficulty due to the observed damage on the post.The overall complaint was confirmed as the observed condition of the corail amt neck seg 135d std would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to an unintended use error, and it has been determined that no corrective and/or preventative action is required.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.H11 additional narrative: corrected: d4 primary udi number, h3.

• Brand Name: CORAIL AMT NECK SEG 135D STD
• Common Device Name: FEMORAL TRIALS
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19665355
• Report Number: 1818910-2024-14586
• Device Sequence Number: 6848521
• Product Code: LXH
• UDI-Device Identifier: 10603295258179
• UDI-Public: (01)10603295258179(10)SO2025850
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/03/2024

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: L94005
• Device Lot Number: SO2025850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 08/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/09/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2016
• 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