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

Catalog Number 256193 (US: 266141)

Device Problems Cut In Material (2454); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  malfunction  

Event Description

Contrôle de la tenue du greffon sous arthroscopie lors de la mise en place de la vis d'interférence cols : le greffon ne tient pas.Ablation de la vis et du greffon puis constat de la rupture de la bandelette.Control of the graft hold under arthroscopy when placing the interference cols screw: the graft does not hold.Removal of the screw and the graft, and then noting the rupture of the anchoring tape.

• Brand Name: COLS
• Type of Device: 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: renaud ruillier ; 3 rue de la forêt; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 6989674
• MDR Text Key: 91939896
• Report Number: 3003898228-2017-00010
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03661489561931
• UDI-Public: (01)03661489561931(17)211115(10)G02531
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 256193 (US: 266141)
• Device Lot Number: G02531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1