MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT TRL38MM; ATTUNE INSTRUMENTS : PATELLA TRIALS

Catalog Number 254501028

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that the peg of 38 dome trial is missing and trial is damaged.

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.

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: a1, b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (updated pe code to broken (2+ pieces): intraoperatively : fragment removed from wound).

Event Description

Additional information was received: 1.The pegs of the patella were broken.They were retrieved but thrown away with how small they were.2.There was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that the peg of 38 dome trial is missing and trial is scraped.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the attune medial dome pat trl38mm has broken one of the three post, the broken fragment was not returned for evaluation.Additionally the device presents scratches at the anterior surface.The observed condition of the device was consistent with overload through the use of excessive force and suspected inappropriate extraction technique during the trialing process.The overall complaint was confirmed as the observed condition of the attune medial dome pat trl38mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended user 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 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.

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 MEDIAL DOME PAT TRL38MM
• Type of Device: ATTUNE INSTRUMENTS : PATELLA 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 ; 3035526892
• MDR Report Key: 18894824
• MDR Text Key: 337556151
• Report Number: 1818910-2024-05717
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295136057
• UDI-Public: 10603295136057
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 254501028
• Device Lot Number: MVMGSQ500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/20/2024; 04/09/2024; 04/16/2024
• Supplement Dates FDA Received: 03/25/2024; 04/10/2024; 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• 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