MAUDE Adverse Event Report: FH INDUSTRIE ARROW; DRILL SLEEVE

Catalog Number 264479

Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Event Description

Le foret 3.2mm s'est coincé dans le canon de perçage.Les 2 pièces sont devenues inutilisables et n'ont pas pu être séparées.A 3.2 mm drill bit (# 267115) became bound up and cold-welded into the drill sleeve (# 264479).Once this occurred, the drill bit and and drill sleeve were no longer usable.

• Brand Name: ARROW
• Type of Device: DRILL SLEEVE
• 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: 6989679
• MDR Text Key: 91328421
• Report Number: 3003898228-2017-00009
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/20/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 264479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1