MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RV RMR STRT PLT TIP

Catalog Number 321-25-01

Device Problem Break (1069)

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

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, while reaming the glenoid with the reverse pilot starter reamer, the pilot tip portion of the reamer broke off in the male patient¿s glenoid.A midas was used to bur out a portion, however, the piece seemed to go deeper into glenoid and surgeon is unsure the entire piece was removed, a portion is believed to be left in patient.Patient was last known to be in stable condition following the event.Device is to be returned.

Manufacturer Narrative

(h3) the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip fracture.(h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z-2663-2017, z-2664-2017, z-2665-2017, z-2666-2017, z-2668-2017, z-2668-2017.

• Brand Name: EQUINOXE
• Type of Device: MDLR RV RMR STRT PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12681544
• MDR Text Key: 277908059
• Report Number: 1038671-2021-00552
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862087614
• UDI-Public: 10885862087614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 321-25-01
• Device Lot Number: 105364044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male