MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 6MM CANNULATED; BIT, DRILL

Model Number	DRILL, 6MM CANNULATED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/22/2019
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 that during a shoulder arthroplasty procedure, a small piece of metal from the 6.0 cannulated drill (ar-9216-3) broke off in the patient's glenoid.It was not known at the time of the surgery ((b)(6) 2019) and was discovered when the patient came in for a routine follow up xray in (b)(6).There were no issues during the procedure or with the patient at follow up.No revision is planned.There is a small piece of metal visible on xray in the glenoid vault.Additional information provided 10/1/2019: the patient is not experiencing discomfort.The fragment appears to be contained in the vault.

• Brand Name: DRILL, 6MM CANNULATED
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9225721
• Report Number: 1220246-2019-01372
• Device Sequence Number: 150603
• Product Code: HTW
• UDI-Device Identifier: 00888867192621
• UDI-Public: 00888867192621
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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: DRILL, 6MM CANNULATED
• Device Catalogue Number: AR-9216-3
• Device Lot Number: 021548
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other