MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW GLENOSPHERE Ø39

Catalog Number 260567

Device Problem Misassembly by Users (3133)

Patient Problem No Information (3190)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

Installation failure: the screw did not hold for fixing the glenosphere to the metal-back while the metal-back was in place.The surgeon tried several times to hold the screw in place but without success.Changing the glenosphere and the screw.

• Brand Name: ARROW
• Type of Device: ARROW GLENOSPHERE Ø39
• 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: 9816993
• MDR Text Key: 200627421
• Report Number: 3003898228-2020-00003
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: ET
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 260567
• Device Lot Number: J01031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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
• Patient Outcome(s): Other