MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR CNLTD TRIDRV DRVR

Catalog Number 315-25-00

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that the surgeon was using the modular driver to ream the glenoid when the spring-loaded end connector came apart.The collar, spring, and ball barring fell off the driver.The patients¿ health was not compromised.All parts of the driver were taken out before the surgeon closed the patient.

Manufacturer Narrative

Section h10: (h3) this broken tri-drive reported was likely the result of holding the sleeve stationary while the instrument was spinning or the tri-drive contacting a retractor, which led to the retaining ring breaking loose from the assembly, allowing the tip to disassemble.Capa 2019-44 has been opened to further investigate this issue.(h6) evaluation codes: 2199, 1069.Section h11: the following sections have corrected information: (g4) initial awareness date in initial submission should have been 05-jul-2019.

• Brand Name: EQUINOXE
• Type of Device: MDLR CNLTD TRIDRV DRVR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9115199
• MDR Text Key: 189074775
• Report Number: 1038671-2019-00467
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315-25-00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention