MAUDE Adverse Event Report: TEKNIMED SAS EUROSCREW TCP NG; BIODEGRADABLE BONE SCREW

Catalog Number	T730924NG
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient operated on her knee tibia for acl surgery on (b)(6) 2022 has complained of discomfort in the knee.After checking it, turned out that the screw installed at the time had broken in two with the head which had gone up into the knee (intra-articular tibial migration post initial surgery).An additional surgical intervention has been performed to extract the screw on (b)(6) 2024.After the additional surgical intervention, the patient is doing well.

• Brand Name: EUROSCREW TCP NG
• Common Device Name: BIODEGRADABLE BONE SCREW
• Manufacturer (Section D): TEKNIMED SAS; 8 rue du corps franc pommies; vic-en-bigorre, 65500 ; FR 65500
• Manufacturer (Section G): TEKNIMED SAS; 8 rue du corps franc pommies; vic-en-bigorre, 65500 ; FR 65500
• Manufacturer Contact: stéphanie salles ; 8 rue du corps franc pommies; vic-en-bigorre, 65500 ; FR 65500
• MDR Report Key: 20758680
• Report Number: 9615788-2024-00001
• Device Sequence Number: 15826050
• Product Code: MAI
• UDI-Device Identifier: 03760177042827
• UDI-Public: 03760177042827
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K230394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: T730924NG
• Device Lot Number: 7320301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2020
• 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 Age: 56 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 72 KG