MAUDE Adverse Event Report: FH INDUSTRIE COLS; COLS TENDON ANCHORING TAPE

Model Number	25619366141
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the use of tls tape through tibia tunnel the tape broke and only few fribes kept the graft.
Event or Problem Description
During the use of tls tape through tibia tunnel the tape broke and only few fribes kept the graft.

• Brand Name: COLS
• Common Device Name: COLS TENDON ANCHORING TAPE
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: cécilia hernoux ; 3 rue de la forêt; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 13579750
• Report Number: 3003898228-2022-00001
• Device Sequence Number: 11922840
• Product Code: MBI
• UDI-Device Identifier: 03661489661419
• UDI-Public: 03661489661419
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K120740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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 Expiration Date: 03/31/2026
• Device Model Number: 25619366141
• Device Lot Number: L04787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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: Female
• Patient Weight: 96 KG