MAUDE Adverse Event Report: ARTHREX, INC. COMPRESSION SCREW CANLTD DRILL BIT 26MM; BIT, DRILL

Catalog Number	AR-5025TDC-26
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/07/2016
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 device was received and an evaluation was conducted.The complaint was confirmed.Lot number was not provided so device history record review cannot be performed.The device met all material specifications as received.The evaluation revealed a torsional break on broken tip.Complainant's event 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.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 while drilling in the medial condyle for a compression screw for a knee scope-ocd repair, pieces of the drill broke off.When the drill was removed the k-wire was lodged in the cannulation.It was bent and removed on the back table.It was not realized until the conclusion of drilling that the fragments were missing.The fragments were left in the bottom of the socket and were confirmed by x-rays.It was reported that the result of the case was unaffected by the drill fragments and the surgeon was satisfied with the compression and fixation of the chondral defect.

• Brand Name: COMPRESSION SCREW CANLTD DRILL BIT 26MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6022130
• Report Number: 1220246-2016-00427
• Device Sequence Number: 544987
• Product Code: HTW
• UDI-Device Identifier: 00888867034976
• UDI-Public: 00888867034976
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/23/2016

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-5025TDC-26
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2016
• Initial Report FDA Received Date: 10/12/2016
• 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