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

Catalog Number AR-8005D-30

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/04/2016

Event Type  Injury  

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 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.

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 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
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6150694
• MDR Text Key: 61605432
• Report Number: 1220246-2016-00554
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888867042438
• UDI-Public: 00888867042438
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR