MAUDE Adverse Event Report: ARTHREX, INC. STEP DRILL, BIO-SUTURETAK; BIT, DRILL

Catalog Number	AR-1934D-24
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/14/2016
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review cannot be performed as the lot number is unknown.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported via a medwatch ((b)(4)) that the drill bit broke off in the bone and that the surgeon left it in because it reportedly would cause more harm trying to retrieve the broken piece than leaving it in.X-ray performed on area to determine action.It was an arthrex 2.4 suture tak drill bit, ar-1934d-24.Report states they are aware of no patient injury at the time.

• Brand Name: STEP DRILL, BIO-SUTURETAK
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6132363
• Report Number: 1220246-2016-00523
• Device Sequence Number: 1075949
• Product Code: HTW
• UDI-Device Identifier: 00888867024045
• UDI-Public: 00888867024045
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2016

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-1934D-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 11/29/2016
• 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