MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; DRILL BIT

Device Problem Break (1069)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

As reported, during a procedure, the drill bit broke inside drill guide and now is cold welded inside guide.There were no issues with the patient.The device is available for return.

Manufacturer Narrative

Pending evaluation.

Manufacturer Narrative

Section h10: (h3) the jammed devices reported were likely the result of deformation on the inner surface of the drill guide and outer surface of the drill bit, which led to galling and eventually prevented the drill bit from passing through.The broken drill bit was likely the result of applying a bending moment while drilling and during an attempt to remove the drill from the drill guide, which led to ultimate fracture of the device on both sides.

• Brand Name: EQUINOXE
• Type of Device: DRILL BIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gaiensville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12810431
• MDR Text Key: 285247149
• Report Number: 1038671-2021-00617
• Device Sequence Number: 1
• Product Code: KWT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2022
• 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