MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV TC3 BOX TRIAL SZ5; FEMORAL TRIALS

Catalog Number	201103015
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the box trial no longer connects to femur.It was unknown about surgical delay.
Additional Manufacturer Narrative
Product complaint # = > pc-(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.
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).Investigation summary: it was reported that the box trial no longer connects to femur.It was unknown about surgical delay.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the sig hp rev tc3 box trial sz5.The allegation cannot be confirmed.A dimensional inspection for the sig hp rev tc3 box trial sz5 and met specifications.The overall complaint was unconfirmed as the observed condition of the sig hp rev tc3 box trial sz5 would not 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 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.********************************************************************** the following drawings reflecting the current and manufactured revisions were reviewed: dwg-201103015 rev.E (only current was reviwed) dep01848 rev.B (only current was reviewed ) dimensional inspection: specified dimensions: insertion hole ø = 8.38 mm +/- 0.03mm measured dimensions: insertion hole ø = 8.39 mm device used mitutoyo digimatic caliper serial no.(b)(6) calibration id: cd78621 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.

• Brand Name: SIG HP REV TC3 BOX TRIAL SZ5
• 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 ; 3035526892
• MDR Report Key: 18434866
• Report Number: 1818910-2024-00195
• Device Sequence Number: 6950097
• Product Code: HWT
• UDI-Device Identifier: 10603295081364
• UDI-Public: 10603295081364
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 01/03/2024

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: 201103015
• Device Lot Number: SO2002020
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 01/26/2024; 02/08/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/29/2024; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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 Age: 63 YR
• Patient Sex: Male