MAUDE Adverse Event Report: ARTHREX INC. 2.5MM DRILL BIT; BIT, DRILL

Catalog Number	AR-8943-30
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/28/2017
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 device was received and an evaluation was conducted.The complaint was confirmed.Device history record revealed nothing relevant to this event.The evaluation revealed that the drill's flute was broken-off.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 causes of this event are being 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 the or staff reported that during an ankle fracture procedure while the surgeon was drilling into the tibia; the tip broke off in the patient's tibia.The surgeon attempted to retrieve the tip, but was unsuccessful.The tip of the reamer was left in the patient.Patient: (b)(6) male.Caller did not have any additional details to provide.Follow-up investigation: per the sales rep, the bone was reported to be hard and the surgeon was applying a lot of pressure on the drill bit and it broke.

• Brand Name: 2.5MM DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6893456
• Report Number: 1220246-2017-00358
• Device Sequence Number: 10939162
• Product Code: HTW
• UDI-Device Identifier: 00888867052376
• UDI-Public: 00888867052376
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/06/2017

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-8943-30
• Device Lot Number: 1391539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/26/2017
• 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: 44 YR