MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US STD NECK SEGMENT CORAIL AMT; FEMORAL TRIALS

Catalog Number	L20431
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.
Event or Problem Description
It was reported that the tip of the size 8 broach appeared to have a defect which would not allow the neck to sit flush.There was no impact to the patient; there was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "the tip of the size 8 broach appears to have a defect which would not allow the neck to sit flush." the product was not returned to medtech orthopaedics, however photos were provided for review.See ¿img_2324.Jpeg¿ and ¿img_2325.Jpeg.¿ the photo investigation revealed that 'l20431, std neck segment corail amt¿ had stripped neck and the condition of the post is an indication of assembly issues.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion while trialing.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the std neck segment corail amt would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use for stripped, component failure for unable to assemble 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.H11 additional narrative: added: d4 lot.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).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: d9.Corrected: d4 primary udi number.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 size 8 broach appears to have a defect which would not allow the neck to sit flush.Please see photos." the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the std neck segment corail amt presents circular markings around the surface of the post.Additionally, it was deformed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion while trialing.A functional test was performed with a mating device and confirmed that the std neck segment corail amt was not able to fully assemble the handle, most likely due to the observed condition of the post.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, 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: added: d9.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information received, "the tip of the size 8 broach appears to have a defect which would not allow the neck to sit flush." the product was not returned to (b)(4), however photos were provided for review.The photo investigation revealed that 'l20431, std neck segment corail amt¿ had stripped neck and the condition of the post is an indication of assembly issues.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion while trialing.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the std neck segment corail amt would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use for stripped, component failure for unable to assemble 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 (b)(4) 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.

• Brand Name: STD NECK SEGMENT CORAIL AMT
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21655346
• Report Number: 1818910-2025-04282
• Device Sequence Number: 7489635
• Product Code: LXH
• UDI-Device Identifier: 10603295258216
• UDI-Public: (01)10603295258216(10)2336332
• 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

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: L20431
• Device Lot Number: 2336332
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 04/11/2025; 05/19/2025; 05/23/2025; 06/02/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 03/31/2025; 04/16/2025; 05/20/2025; 05/26/2025; 06/03/2025
• 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