MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 4MM CANNULATED; BIT, DRILL

Model Number	DRILL, 4MM CANNULATED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/21/2018
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 is expected but has not returned for evaluation.The 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 procedure, the 4mm cannulated drill broke and the fragment was not able to be retrieved from patient body.No further information.Additional information has been requested.Additional information obtained: this was acl reconstruction procedure.When the surgeon inserted the drill through the guide, the drill broke.He tried to retrieve fragment, but was unsuccessful and the fragment remained in the patient.The patient is male, (b)(6).

• Brand Name: DRILL, 4MM CANNULATED
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7693342
• Report Number: 1220246-2018-00555
• Device Sequence Number: 19044528
• Product Code: HTW
• UDI-Device Identifier: 00888867087774
• UDI-Public: 00888867087774
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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 Expiration Date: 02/28/2023
• Device Model Number: DRILL, 4MM CANNULATED
• Device Catalogue Number: AR-1218-40
• Device Lot Number: 10194771
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/17/2018
• 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
• Patient Age: 21 YR