MAUDE Adverse Event Report: ARTHREX, INC. 2.5MM DRILL BIT, CALIBRATED; BIT, DRILL

Model Number	2.5MM DRILL BIT, CALIBRATED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed, the device broke off about 1.46 in from the distal end.The most likely cause is prying and/or leveraging the device during use.
Event or Problem Description
It was reported during a procedure as the surgeon was using the ar-8943-42, 2.5 mm drill bit to drill the pilot hole through the drill guide for the percutaneous calcaneus plate, the tip of the drill broke leaving approximately 3 cm in the bone.The rep stated the broken piece could not be retrieved.The case was completed.Additional information received on 07/16/2019: the procedure taking place was a calcaneus fx procedure.The rep stated there were not any attempts made to remove the broken fragment.The surgeon took an x-ray and it was discovered that the drill bit was below the bone and plate.Two or three screws were already in the plate by this time.The surgeon left the broken drill bit piece in calcaneus and filled the remaining screw holes.There is not a plan to perform a revision/removal procedure at this time, and there are not any available pictures.The device came within set ar-8950s (lot: 43900).

• Brand Name: 2.5MM DRILL BIT, CALIBRATED
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8845622
• Report Number: 1220246-2019-01220
• Device Sequence Number: 2730648
• Product Code: HTW
• UDI-Device Identifier: 00888867052499
• UDI-Public: 00888867052499
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2.5MM DRILL BIT, CALIBRATED
• Device Catalogue Number: AR-8943-42
• Device Lot Number: 021803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/31/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR