MAUDE Adverse Event Report: ARTHREX, INC. DRILL SAW SPORTS 400; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DRILL SAW SPORTS 400
Health Effect - Clinical Codes	Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported during a foot procedure the ar-400 drill was shredding k-wire.The k-wire was replaced but the same event occurred.The shredding of the k-wire caused debris inside the wound.The doctor removed as much debris as he could.The drill was replaced and the case was completed without further issues.After a week postop the patient developed an infection.Follow up dos (b)(6): infection was found (b)(6) and there are x-rays.An ar-400pd (pin drive attachment) was being used with the drill.Additional information obtained 05/13/2020: the patient's original procedure was a fracture, open, foot metatarsal, left.The facility has confirmed that there were no remnants from the drill itself in the patient.Only k-wire remnants remained in the patient.The same drill had been used in prior cases but the drill was taken out of service immediately following this incident.The facility reporter provided part number information for the k-wire used during the patient's procedure.The part number info provided is as follows: part #1600-1654, lot#0418323390 k-wire 1.4mm(0.054") x 152mm (6") this part number is another manufacturer's product (microaire).Additional information obtained 05/13/20: the facility has provided additional information that not one but two different manufacturer's k-wire (microaire and mckesson) shredded while using the arthrex ar-400 drill.The facility has indicated that they feel the drill is the issue causing the shredding since it occurred with more than one manufacturer's (non-arthrex) k-wires.
Additional Manufacturer Narrative
Complaint not confirmed.The returned ar-400 drill was assembled with a known good battery (ar-400ub), pin driver attachment (ar-400pd), and k-wire; since, the original battery, driver attachment, k wire involved in the case were not returned for evaluation.The device was then tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The drill function as intended.The cause is undetermined.

• Brand Name: DRILL SAW SPORTS 400
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10108902
• Report Number: 1220246-2020-01867
• Device Sequence Number: 16995824
• Product Code: HWE
• UDI-Device Identifier: 00888867223318
• UDI-Public: 00888867223318
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: DRILL SAW SPORTS 400
• Device Catalogue Number: AR-400
• Device Lot Number: 10163945
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other