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

Catalog Number	AR-8943-42
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2017
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.No device malfunction can be identified.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device was discarded by the facility.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device history record review revealed nothing relevant to this event.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 talonavicular fusion procedure, the surgeon drilled the first locking hole and then drilled the second locking hole.There is a possibility that the second locking hole was in trajectory of the k-wire holding arthrodesis site together.The surgeon had a bit of difficulty using the 2.5 mm drill bit on the second hole, but eventually plunged through what he thought was the far cortex.Depth gauge was difficult to place through the medial hole (second locking hole drilled) but eventually got depth.Two locking screws were placed, followed by two non-locking screws.The bio was stabilized by the locking guide which made the breakage very suspect and unnoticed until fluoro was used for the final image.Case was finished as booked, although the 2 cm piece of 2.5 mm drill bit is now in the cuboid and possibly the subtalar joint.The rep is not sure if patient will need a second surgery and will be following up with the surgeon.

• Brand Name: 2.5MM DRILL BIT, CALIBRATED
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6731383
• Report Number: 1220246-2017-00283
• Device Sequence Number: 1371939
• Product Code: HTW
• UDI-Device Identifier: 00888867052499
• UDI-Public: 00888867052499
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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-8943-42
• Device Lot Number: 10084406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 07/21/2017
• 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