MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ANTERIOR APPROACH CASE COMPL; HIP INSTRUMENTS : INSTRUMENT CASES

Catalog Number 259807310

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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 Description

This event included trays being rejected due to integrity concerns of the inside of the trays which resulted in small back specks being observed at the bottom of the trays upon opening the trays for a surgical procedure.The contamination of the trays included primary trays and back-up trays and resulted in a case cancellation due to not having the appropriate trays to proceed with the case.

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: e1 facility name, e3 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e2, h6 health effect - impact code.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "this email is to report a compliance concern for the depuy anterior hip trays.This event occurred on 2/22/24 and included a total of 8 trays being rejected due to integrity concerns of the inside of the trays which resulted in small back specks being observed at the bottom of the trays upon opening the trays for a surgical procedure.The contamination of the trays included primary trays and back-up trays and resulted in a case cancellation due to not having the appropriate trays to proceed with the case" the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4) image 26 feb 2024 (1).(b)(4) image 26 feb 2024 (2).(b)(4)image 26 feb 2024 (3).(b)(4) image 26 feb 2024 (4).(b)(4)image 26 feb 2024 (5).(b)(4) image 26 feb 2024 (7).(b)(4) image 26 feb 2024 (9).(b)(4) image 26 feb 2024 (10).(b)(4)image 26 feb 2024 (11).(b)(4) image 26 feb 2024 (12).(b)(4) image 26 feb 2024 (6).(b)(4) image 26 feb 2024 (8).The photo/x-ray investigation revealed that anterior approach case compl had small back specks at the bottom of the tray.The observed condition is likely due to improper cleaning/sterilization.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the anterior approach case compl would 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 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: 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: ANTERIOR APPROACH CASE COMPL
• Type of Device: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 18855142
• MDR Text Key: 337085156
• Report Number: 1818910-2024-05275
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295148258
• UDI-Public: 10603295148258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 259807310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1