MAUDE Adverse Event Report: ARTHREX, INC. DISP INSTR KIT FOR MICRO S-TAK; BIT, DRILL

Catalog Number	AR-1320DSC
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2017
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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not yet returned for evaluation 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.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 shoulder arthroscopy case, the tip of the drill bit that's included with the disposable instrument kit for micro suture-tak, broke off into the patient's bone.The surgeon performed an x-ray to confirm if the piece was still in the patient and it was.No attempts were made to retrieve the piece as it was too far lodged into the patient's bone.

• Brand Name: DISP INSTR KIT FOR MICRO S-TAK
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6371759
• Report Number: 1220246-2017-00048
• Device Sequence Number: 442987
• Product Code: HTW
• UDI-Device Identifier: 10888867009858
• UDI-Public: 10888867009858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/03/2017

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 Expiration Date: 05/01/2020
• Device Catalogue Number: AR-1320DSC
• Device Lot Number: 1288084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial 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