MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 4 MM CANNULATED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DRILL, 4 MM CANNULATED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/27/2019
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 the surgeon was performing a left shoulder orif of distal clavicle fracture, open coracoclavicular ligament repair with twin tail tightrope augmentation.During use of the 4 mm cannulated drill, ar-1204l, appropriate position for the medial drill tunnel on the clavicle was determined, then drilled.The reamer had a small burr on the tip and as the segment was reamed, a small fragment of the end of the reamer broke off in the middle of the clavicle.The broken tip was not in a bad place, and the decision was made to leave it where it was, as it was not possible to fish it out without opening the clavicle up.Additional information provided 10/8/2019: fluoro was used to identify the location of the fragment, so there is not a radiology report available.The tip was secured by the bone itself.No other securement was done to the or manager¿s knowledge.The drill that was involved is retained by risk management and will not be returned.

• Brand Name: DRILL, 4 MM CANNULATED
• 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: 9225755
• Report Number: 1220246-2019-01373
• Device Sequence Number: 19305830
• Product Code: HWE
• UDI-Device Identifier: 00888867004658
• UDI-Public: 00888867004658
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• 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, 4 MM CANNULATED
• Device Catalogue Number: AR-1204L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other