MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 TRUMATCH CT CUT GUIDE KIT L; TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	420915
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that the instrument was no fit properly.The issue was occurred on (b)(6) 2023.Surgeon had to trip off osteophytes for the guide to still not fit properly.It was not able to key the guide in on the anterior flange.A few minute surgical delay to play around with guide.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence was not able to observe defects or signs of a product malfunction.The investigation could not confirm the reported event.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 record evaluation was performed for the finished device product description: trumatch ct cut guide kit l product code: 420915 lot number: tmk00045840 and no non-conformances or manufacturing irregularities were identified device history review : a manufacturing record evaluation was performed for the finished device product description: trumatch ct cut guide kit l product code: 420915 lot number: tmk00045840 and no non-conformances or manufacturing irregularities were identified.
Event or Problem Description
Additional information received.A.Was there a surgical delay? if yes, what is the duration of the delay? -1 minute to adjust the guide.B.Was there any impact on the patient? if yes, please clarify in detail.-no pt impact.
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: TRUMATCH CT CUT GUIDE KIT L
• Common Device Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16551639
• Report Number: 1818910-2023-05955
• Device Sequence Number: 5088546
• Product Code: NJL
• UDI-Device Identifier: 10603295384854
• UDI-Public: 10603295384854
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 03/16/2023

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 Model Number: 420915
• Device Catalogue Number: 420915
• Device Lot Number: 00045840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 03/20/2023; 03/24/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 03/23/2023; 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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