MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FEMORAL TRIAL GRIPPER; EXTRACTION INSTRUMENTS

Catalog Number	254500366
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
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.
Event or Problem Description
It was reported that the holder device was locked closed and would not open.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: it was reported, that the holder device was locked closed and would not open.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed, that attune femoral trial gripper was found with the inner mechanism stuck.And its unable to be opened.The allegation can be confirmed.No other defect was found.The femoral trial gripper should not be used to fully seat the trials, as the prongs protrude past the distal surface of the trial.The femoral trial gripper can be used for sizes 3 - 10 only.When extracting the trial, rocking it medio-laterally may cause condylar fracture.Such rocking should be avoided.A dimensional inspection was performed.For the attune femoral trial gripper was not performed, as it is not applicable to the complaint condition.The overall complaint was confirmed.As the observed, condition of the attune femoral trial gripper would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.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: 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 records evaluation (mre) was not performed.
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).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.

• Brand Name: ATTUNE FEMORAL TRIAL GRIPPER
• Common Device Name: EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17965345
• Report Number: 1818910-2023-21362
• Device Sequence Number: 6715772
• Product Code: HWT
• UDI-Device Identifier: 10603295445241
• UDI-Public: 10603295445241
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/19/2023

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: 254500366
• Device Lot Number: GM5840406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 11/01/2023; 11/08/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 10/20/2023; 11/02/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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