MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL DRILL, 2.0 MM; BIT, DRILL

Model Number	HUMERAL DRILL, 2.0 MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2020
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 via fda medwatch letter (mw5097977) that an arthrex drill bit (ar-7720-2.0, lot unknown) broke off in the patient's left humerus bone.The drill bit piece was too small to remove without causing damage.Additional information obtained 12/15/20: the procedure was a left elbow ulnar collateral ligament repair, ulnar nerve neuroplasty, with tendon graft from right knee.Drill bit lot number unknown.The piece of drill bit was left in because it could not be retrieved without causing damage.No unplanned or larger incisions were needed and the surgeon did not have to change the planned surgical technique.Procedure was completed as planned.Device is not available to return for evaluation.Facility indicated it may have been discarded after the procedure.

• Brand Name: HUMERAL DRILL, 2.0 MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11075963
• Report Number: 1220246-2020-02438
• Device Sequence Number: 3066299
• Product Code: HTW
• UDI-Device Identifier: 00888867042124
• UDI-Public: 00888867042124
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

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: HUMERAL DRILL, 2.0 MM
• Device Catalogue Number: AR-7720-2.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other