MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW STD HUMERAL INSERT D39 H00

Catalog Number	265144
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Intraprosthetic fracture of the reverse arrow prothesis ( placed 10 years old).Morse taper fracture on humeral stem = dislocation of the shoulder.

• Brand Name: ARROW
• Common Device Name: ARROW STD HUMERAL INSERT D39 H00
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 8115049
• Report Number: 3003898228-2018-00020
• Device Sequence Number: 19275249
• Product Code: KWS
• UDI-Device Identifier: 03661489651441
• UDI-Public: 03661489651441
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 265144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention