MAUDE Adverse Event Report: FH INDUSTRIE ARROW SHOULDER; HUMERAL ARROW STEM

Catalog Number 260519

Device Problems Device Reprocessing Problem (1091); Device Maintenance Issue (1379); Device Issue (2379)

Patient Problem No Code Available (3191)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

Number: 0000000260519, designation: tige humerale arrow diam.12 lg 130mm, lot: f02757, quantity: 1, n customer/customer/city: (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm f02757, 1, (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm f02757, 1, (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm f02757, 2, (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm, f02757, 1, (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm, f02757, 1, (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm, f02757, 1, (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm, f02757, 1, (b)(6); 0000000260519, tige humerale arrow diam.12 lg 130mm, f02757, 1, (b)(6).

Event Description

Power failure the laundry on a washing tank between (b)(6) 2016.

Manufacturer Narrative

Number description lot quantity n customer /city 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 1 (b)(6) (b)(6); 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 1 (b)(6) (b)(6); 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 2 (b)(6) (b)(6); 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 1 (b)(6) (b)(6); 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 1 (b)(6) (b)(6); 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 1 (b)(6) (b)(6); 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 1 (b)(6) (b)(6); 0000000260519 tige humerale arrow diam.12 lg 130mm f02757 1 (b)(6) (b)(6).

Event Description

Power failure the laundry on a washing tank between (b)(6) 2016.

• Brand Name: ARROW SHOULDER
• Type of Device: HUMERAL ARROW STEM
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, france 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, france 29000 ; FR 29000
• Manufacturer Contact: ruillier renaud ; 3 rue de la forêt; heimsbrunn, france 68990
• MDR Report Key: 5675259
• MDR Text Key: 45757693
• Report Number: 3003898228-2016-00006
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: 260519
• Device Lot Number: F02757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1