MAUDE Adverse Event Report: COULOT DÉCOLLETAGE TRYPTIK 2 C-PLATE, PLATE 4-LEVEL

Model Number	TRY-CP 10 76-S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), 2023, we received a complaint from the field (see (b)(4)) reporting a serious injury field event.The patient was operated on (b)(6) 2023.The patient came to the emergency room 3 days after the surgery, on (b)(6) 2023.Tests were performed and it was found that the nitinol ring was damaged, causing a perforation of the esophagus.
Additional Manufacturer Narrative
The customer complaint form reports: "the patient came to the emergency room 3 days after the operation, tests were performed and it was found that the nitinol ring was damaged, causing a perforation of the esophagus.I will provide more information." then, we have been informed that the patient was reoperated 2 days after the first surgery and that he is in a well-being (see email on 08.Sep.2023).The manufacturing folder has been reviewed.Complained device belongs to a batch of (b)(4) units manufactured in september 2018, 14 devices have already been implanted with no issue and this is the first complaint we receive for this type of defect.The analysis on the manufacturing documents and control quality documents detected that raw materials and production processes were conforming to the specifications.We received the immediate post-operative pictures; they did not allow us to detect any issue.We received two pictures after the revision surgery, they did not allow us to detect any issue.We did not receive any picture before the revision surgery, but we were told that the nitinol ring was detached.During the revision surgery they did remove it and keep the screw in.The involved ring has been scrapped on site and the device was left implanted so we could not inspect the complained device (and no picture is available), but we have been informed that the surgeon did not use the ads guide (see email on 08.Sep.2023).As per the surgical technique (b)(4) (step 6), this practice could damage the device because it could affect the locking ring integrity.Since the launch of the product, 7077 plates have been implanted.We received 13 complaints for this issue, there is therefore a rate of 0,18%.This rate is low, we close the case as is with no further action but we decided to inform the national competent authority (aemps) via mir-13-2023.
Event or Problem Description
On july 31, 2023, we received a complaint from the field (see cpt-2497) reporting a serious injury field event.The patient was operated on (b)(6) 2023.The patient came to the emergency room 3 days after the surgery, on (b)(6) 2023.Tests were performed and it was found that the nitinol ring was damaged, causing a perforation of the esophagus.

• Brand Name: TRYPTIK 2 C-PLATE, PLATE 4-LEVEL
• Common Device Name: TRYPTIK 2 C-PLATE, PLATE 4-LEVEL
• Manufacturer (Section D): COULOT DÉCOLLETAGE
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 17539603
• Report Number: 3007728266-2023-00003
• Device Sequence Number: 12353175
• Product Code: KWQ
• UDI-Device Identifier: 07640178974869
• UDI-Public: (01)07640178974869
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/26/2026
• Device Model Number: TRY-CP 10 76-S
• Device Catalogue Number: TRY-CP 10 76-S
• Device Lot Number: 4-2889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female