MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW SCREWDRIVER 3.5

Catalog Number 264683

Device Problems Accessory Incompatible (1004); Compatibility Problem (2960)

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

Event Date 10/22/2018

Event Type  malfunction  

Event Description

While doing a revision rsa using custom implants and v12 instrument set, we were not able to get the glenosphere screw to fully engage with metal back glenoid (size 46 lp).Glenosphere and fh metal back glenoid had to be removed and replaced with djo encore baseplate and glenosphere.Fh stem stayed in place and custom humeral head (b)(4) was implanted ((b)(4)) after the case it was discovered that due to v12 screwdriver's tapered design, it is impossible for the screwdriver to fully go down screw shaft on 44 implant.No consequence for the patient.

• Brand Name: ARROW
• Type of Device: ARROW SCREWDRIVER 3.5
• 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: cécilia hernoux ; 3 rue de la fôret; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 8163616
• MDR Text Key: 130493104
• Report Number: 3003898228-2018-00021
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03661489646836
• UDI-Public: 03661489646836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D114497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 264683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other