MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 135D STD; FEMORAL TRIALS

Catalog Number	L94005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the corail std trial neck segment was broken.Nothing noted by scrub team during procedure, but after processing in cssd it has been noted that the green coloured insert in the trial segment has broken loose and is no longer part of the trial.
Additional Manufacturer Narrative
Product complaint #(b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.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: no change to the normal patient status/outcome at this stage.Normal post-op procedures being followed.Nothing to report of infection post-op at this stage.
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).Investigation summary according to the information received, it was reported that a corail std trial neck segment (l20431) used today from [hospital] consigned corail set being noted as being broken after cssd processing.Nothing noted by scrub team during procedure.But after processing in cssd it has been noted that the green coloured insert in the trial segment has broken loose and is no longer part of the trial.Surgeon informed that there is a piece missing and unsure whether it may or may not be lost inside the patient.Surgeon has noted that he will keep an eye on the patient for any signs of infection or irritation outside of ordinary.Request for replacement put through due to "complaint process".Hospital has retained a loan neck segment to cover their consignment set for the interim.The product was not returned to j&j medtech orthopaedics, however a photo was provided for review.See attachment (img_0143.Jpg).The photo investigation revealed the green color indicator was broken.No other defects could be identified.The observed condition could be attributed to unintended use error, this type of damage is likely due to overload in that component when handling or removing the trial neck.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 std neck segment corail amt would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, 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 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 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 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).Investigation summary: according to the information received, it was reported that a corail std trial neck segment (l20431) used today from [hospital] consigned corail set being noted as being broken after cssd processing.Nothing noted by scrub team during procedure.But after processing in cssd it has been noted that the green coloured insert in the trial segment has broken loose and is no longer part of the trial.Surgeon informed that there is a piece missing and unsure whether it may or may not be lost inside the patient.Surgeon has noted that he will keep an eye on the patient for any signs of infection or irritation outside of ordinary.Request for replacement put through due to "complaint process".Hospital has retained a loan neck segment to cover their consignment set for the interim.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the green color indicator was broken, the indicador was not returned for evaluation.No other defects could be identified.The observed condition could be attributed to unintended use error; this type of damage is likely due to overload in that component when handling or removing the trial neck.A functional inspection was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the std neck segment corail amt would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, 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 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.H11 additional narrative: corrected: h3.

• Brand Name: CORAIL AMT NECK SEG 135D STD
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• 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: 19725329
• Report Number: 1818910-2024-15082
• Device Sequence Number: 8207194
• Product Code: LXH
• UDI-Device Identifier: 10603295325161
• UDI-Public: (01)10603295325161(10)NB15316
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 07/11/2024

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: NB15316
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 09/30/2024; 09/30/2024; 11/15/2024; 12/20/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/24/2024; 09/30/2024; 09/30/2024; 11/18/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2012
• 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: Female