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); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Std 135 corail neck trial locking ring was not sitting flush and has been bent out of its notch meaning the head trials cannot be locked onto this trial.Not usable in current state.
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.
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.H10 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.
Event or Problem Description
Additional information was received: the exact complaint was that the head trial was not locking onto the neck trial due to the locking ring being bent out of shape.
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 that 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 that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "std 135 corail neck trial locking ring was not sitting flush and has been bent out of its notch meaning the head trials cannot be locked onto this trial.Not usable in current state." the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that 'l94005, corail amt neck seg 135d std' had bent.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.The provided evidence was not sufficient to confirm the reported event of unable to assemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the corail amt neck seg 135d std would contribute to the complained device issue.Based on the investigation findings, unintended use error caused or contributed to event and 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 complaint condition.As part of medtech orthopaedics 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 device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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 that 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 that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿std 135 corail neck trial locking ring was not sitting flush and has been bent out of its notch meaning the head trials cannot be locked onto this trial.Not usable in current state¿.The product returned to medtech orthopaedics for evaluation.The medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis revealed that the corail amt neck seg 135d std has the circlips ring deformed.Additionally, the device exhibits an overall worn appearance consistent with normal and constant usage.A functional testing was not performed as the mating device was not returned for evaluation.However, based on the observed condition of the circlips ring, it is reasonable that the deformation contributes to the reported assembling issues.The observed condition of the device appears to be a result from a combination of heavy use and exposure to unintended forces, such as prying motions applied during repeated assembly and disassembly cycles with the mating device.The overall complaint was confirmed as the observed condition of the corail amt neck seg 135d std would have 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 j&j medtech orthopaedics 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.

• 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: 20295574
• Report Number: 1818910-2024-20089
• Device Sequence Number: 20654196
• Product Code: LXH
• UDI-Device Identifier: 10603295325161
• UDI-Public: (01)10603295325161(10)NB104283
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/24/2024

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: NB104283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 10/02/2024; 10/04/2024; 12/03/2024; 12/11/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 09/30/2024; 10/02/2024; 10/07/2024; 12/10/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2015
• 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