MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW QUICK RELEASE TAPERED REAMER

Model Number 269480

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

During the preparation of the glenoid, when drilling the holes for the preparation, there was resistance to drilling.The tapered reamer twisted in the drill guide part.

• Brand Name: ARROW
• Type of Device: ARROW QUICK RELEASE TAPERED REAMER
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH ORTHO; 3 rue de la foret; heimsbrunn, 68990 ; FR 68990
• Manufacturer Contact: cécilia hernoux ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 12010850
• MDR Text Key: 256787996
• Report Number: 3003898228-2021-00001
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K171789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/19/2021

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 Model Number: 269480
• Device Lot Number: CM21885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 06/16/2021
• 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