MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ARTIC/EZE TR BALL GRVD 28+8.5; FEMORAL TRIALS

Catalog Number	253083000
Medical Device Problem Code	Scratched Material (3020)
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
The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, ¿the product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer¿ the product was returned to depuy synthes for evaluation.Additionally, photos of the device were provided for review.Visual analysis of the returned sample revealed that the outer surface of the artic/eze tr ball grvd 28+8.5 presents several deep scratches and nicks.Additionally, the device presents an overall worn condition consistent with normal and constant use for a long period of time.The observed scratches are consistent with other tools and hard 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 and functional testing were not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the artic/eze tr ball grvd 28+8.5 would contribute to a device issue.Based on the investigation findings, the potential cause is traced to unintended use error and end of life, 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 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 : a manufacturing records evaluation (mre) was not performed as no lot number was retrieved for this device due to the returned condition.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.

• Brand Name: ARTIC/EZE TR BALL GRVD 28+8.5
• 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: 19618047
• Report Number: 1818910-2024-14003
• Device Sequence Number: 17883235
• Product Code: HWT
• UDI-Device Identifier: 10603295128960
• UDI-Public: (01)10603295128960
• 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
• Report Date (Section B): 06/26/2024

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: 253083000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/26/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown