MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, CANNULATED, 3.0MM; BIT, DRILL

Catalog Number	AR-8005D-30
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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 device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Complainant's event is typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.
Event or Problem Description
It was reported that during a dorsum of the right foot, the surgeon was drilling the bone with a cannulated 3.0 drill bit when the drill bit broke off into the base of the 2nd metatarsal.The surgeon was unable to retrieve the drill bit from the patient.He went on to drill out the bone with a 3.0 solid drill bit instead.
Additional Manufacturer Narrative
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.This is a follow-up submission due to device evaluation.Complaint confirmed.The device met material specifications as received.The evaluation revealed torsional break on broken drill tip.Complainant's event is typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use this is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be 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 a dorsum of the right foot, the surgeon was drilling the bone with a cannulated 3.0 drill bit when the drill bit broke off into the base of the 2nd metatarsal.The surgeon was unable to retrieve the drill bit from the patient.He went on to drill out the bone with a 3.0 solid drill bit instead.

• Brand Name: DRILL BIT, CANNULATED, 3.0MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6150694
• Report Number: 1220246-2016-00554
• Device Sequence Number: 1057470
• Product Code: HTW
• UDI-Device Identifier: 00888867042438
• UDI-Public: 00888867042438
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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-8005D-30
• Device Lot Number: 040934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 03/02/2017
• 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: 66 YR