MAUDE Adverse Event Report: FH INDUSTRIE ARROW; HUMERAL HEAD

Catalog Number 260550

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916); Failure To Unwrap (2940); Packaging Problem (3007)

Patient Problem Not Applicable (3189)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

Break of internal packaging, guaranteeing sterility, casse de l'emballage - coque interne garantissant la stérilité.

• Brand Name: ARROW
• Type of Device: HUMERAL HEAD
• 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 fôret; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 7340692
• MDR Text Key: 102454068
• Report Number: 3003898228-2018-00005
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: D111428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 260550
• Device Lot Number: RG03181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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
• Patient Outcome(s): Other