MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW BROACH HANDLE

Model Number	261848
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the shoulder surgery the hook which blocks the raps or the stem on the raps handle was stuck.

• Brand Name: ARROW
• Common Device Name: ARROW BROACH HANDLE
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 8411101
• Report Number: 3003898228-2019-00003
• Device Sequence Number: 11227251
• Product Code: LXH
• UDI-Device Identifier: 03661489618482
• UDI-Public: 03661489618482
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: D114497
• 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): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 261848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1