MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW METALBACK GLENOID BASE S44

Model Number 264098

Device Problem Material Frayed (1262)

Patient Problem Not Applicable (3189)

Event Date 10/26/2019

Event Type  malfunction  

Event Description

During an inspection, a deburring defect in the cortical bone screw pitch was detected.The reference concerned is not fda approved.The equivalent reference is (b)(4).

• Brand Name: ARROW
• Type of Device: ARROW METALBACK GLENOID BASE S44
• 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: 9236925
• MDR Text Key: 207538463
• Report Number: 3003898228-2019-00009
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: D154303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: 264098
• Device Lot Number: K00971
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1