MAUDE Adverse Event Report: ARTHREX, INC. STANDARD PROCEDURE PACK; BIT, DRILL

Model Number	STANDARD PROCEDURE PACK
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a fibulock ankle arthroscopy procedure, the surgeon was drilling in the canal with the 3.2mm drill bit that is included in the st6100, standard procedure pack.The drill got up through the fracture site and the surgeon stopped drilling to get an image.When the drill was restarted, the drill bit broke.Most of the fragments were retrieved however, one fragment remained.The case was completed with a drill from a second standard procedure pack, st6100.The surgeon used the unbroken drill bit and the case was completed with no further issues.

• Brand Name: STANDARD PROCEDURE PACK
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7922735
• Report Number: 1220246-2018-00679
• Device Sequence Number: 1624799
• Product Code: HTW
• UDI-Device Identifier: 00816988011989
• UDI-Public: 00816988011989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: 12/01/2019
• Device Model Number: STANDARD PROCEDURE PACK
• Device Catalogue Number: ST6100
• Device Lot Number: A251217-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220246-9/12/18-002-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other