MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; DRILL BIT 2.0MM REPLACED BY 321-20-00

Catalog Number 321-15-06

Device Problem Break (1069)

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

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

During setting and drilling of a reverse shoulder system the 2.0mm drill broke and left approx.15-18mm of the drill bit in the glenoid bone.Surgeon determined that removal of broken drill bit would have required extensive debridement of the glenoid bone potentially compromising the procedure.The remaining glenoid baseplate and remaining assembly was placed and procedure ended well with secure and correct placement of glenosphere.

Manufacturer Narrative

Section h10: (a2) age at the time of event: 59 years.(d4) unique identifier (udi) #: (b)(4).(e3) occupation: physician.(h3) the broken drill bit reported was likely the result of applying a bending moment while drilling, which led to a fracture of the threaded tip that remained captured in the patient¿s glenoid bone.However, this cannot be confirmed since the device was not returned and no further information was provided.

• Brand Name: EQUINOXE
• Type of Device: DRILL BIT 2.0MM REPLACED BY 321-20-00
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8515013
• MDR Text Key: 141957045
• Report Number: 1038671-2019-00244
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 321-15-06
• Device Lot Number: 98102012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR