MAUDE Adverse Event Report: ARTHREX, INC. CALIBRATED DRILL BIT, 3.0MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number CALIBRATED DRILL BIT, 3.0MM

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during an ankle fusion procedure, while the surgeon was under drilling the "home run screw" hole in the anterior ankle fusion plate, the 3.0mm calibrated drill tip broke off inside the patient's talus.The tip was unable to be retrieved from the bone.Proceeding, a 5.5 cancellous screw was placed the same "home run screw" hole with the tip of the drill remaining in the patient.The surgeon placed the 5.5 cancellous screw to try and push the drill tip through the talus and out of the calcaneal, but this was not achieved.The tip stayed in the patient.

• Brand Name: CALIBRATED DRILL BIT, 3.0MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 8739522
• MDR Text Key: 149372300
• Report Number: 1220246-2019-01186
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867133860
• UDI-Public: 00888867133860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CALIBRATED DRILL BIT, 3.0MM
• Device Catalogue Number: AR-8970-30
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other