MAUDE Adverse Event Report: ARTHREX INC. DRILL, CANNULATED, FOR AC REPAIR, 2.4MM; BIT, DRILL

Catalog Number	AR-2257D-24
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Lot number was not provided so device history record review cannot be performed.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an acromion-clavicular joint reconstruction, the surgeon attempted to drill with aid of the drill guide assembly.The drill, ar-2257d-24, did not hit intended target and instead severed an arterial vasculature.The procedure length was therefore significantly increased and patient has suffered potential damage to vasculature and nerves.A second surgery will be needed.Follow-up investigation: the patient underwent autografting on (b)(6) 2018 to reconstruct the severed vasculature.

• Brand Name: DRILL, CANNULATED, FOR AC REPAIR, 2.4MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7467849
• Report Number: 1220246-2018-00153
• Device Sequence Number: 1607840
• Product Code: HTW
• UDI-Device Identifier: 00888867026421
• UDI-Public: 00888867026421
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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 Catalogue Number: AR-2257D-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other