MAUDE Adverse Event Report: FH INDUSTRIE ARROW; INSERT HUMERAL METAL-BACK ARROW DIAM 39 H00

Catalog Number 257060 (US 265144)

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Rupture (2208); Injury (2348)

Event Date 09/26/2017

Event Type  Injury  

Event Description

Break of the humeral insert arrow.Reverse prosthesis in 2014.The patient felt his shoulder go whilst lifting shopping in car.When the surgeon went in, the glenoid sphere was solid although the surgeon does note that the position wasn't perfect.Likewise the stem was also firmly in place.The metal stump of glenoid base had sheared off and had displaced.The surgeon removed stem with the stump in placed and fitted a new one with metal back glenoid base.

• Brand Name: ARROW
• Type of Device: INSERT HUMERAL METAL-BACK ARROW DIAM 39 H00
• 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: 7058448
• MDR Text Key: 92900354
• Report Number: 3003898228-2017-00011
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03661489570605
• UDI-Public: (01)03661489570605(17)180128(10)D00729
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 257060 (US 265144)
• Device Lot Number: D00729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• 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): Required Intervention
• Patient Age: 78 YR