MAUDE Adverse Event Report: FH INDUSTRIE COLS; COLS PEEK SCREW D10 L20

Model Number	266139
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The screw split during implantation in the patient with the screwdriver.The screw was removed, failed and replaced with another one.
Event or Problem Description
The screw split during implantation in the patient with the screwdriver.The screw was removed, failed and replaced with another one.
Event or Problem Description
The screw split during implantation in the patient with the screwdriver.The screw was removed, failed and replaced with another one.

• Brand Name: COLS
• Common Device Name: COLS PEEK SCREW D10 L20
• 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: 14315550
• Report Number: 3003898228-2022-00003
• Device Sequence Number: 20045399
• Product Code: HWC
• UDI-Device Identifier: 03661489661396
• UDI-Public: 03661489661396
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113591
• 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: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2022

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 Model Number: 266139
• Device Lot Number: M00554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 04/12/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/14/2022; 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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: Unknown