MAUDE Adverse Event Report: EXACTECH, INC. FXD ANGL TRQ SCR DRVR; FIXED ANGLE TORQUE DRIVE

Catalog Number 301-11-06

Device Problem Material Separation (1562)

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

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Glenoid disassociated from the cage and one peripheral peg.The glenoid poly component and two peripheral pegs is positioned posterior to the humerus/joint and the cage and one peripheral peg is still stuck in the bone of the glenoid.The humeral head was dis-impacted and the stem came out with it.The primary glenoid component was removed from the joint and the cage and peripheral peg was removed from the glenoid bone.The glenoid was then reamed and re-prepped for re-insertions of an all poly glenoid.A medium beta all poly glenoid implant was cemented in.The humerus was broached up to a 8mm stem and a 0 replicator plate was used.Then a 44mmx17mm humeral head was used for final implants.

Manufacturer Narrative

The engineering evaluation noted that the revision reported was stated to be the result of disassociation of the center cage and one of the three peripheral pegs from the polyethylene body of the glenoid component; the result of this analysis confirmed that observation.The cause of this disassociation was inconclusive though it was likely cause by damage to the central peg at the time of the glenoid implantation or by eccentric humeral head edge loading, as evidence by the burnishing along the peripheral of the glenoid articular body.

• Brand Name: FXD ANGL TRQ SCR DRVR
• Type of Device: FIXED ANGLE TORQUE DRIVE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 8084859
• MDR Text Key: 127606089
• Report Number: 1038671-2018-00877
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 301-11-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 116