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	06/01/2018
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.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.He stopped halfway to snap an x-ray and when he restarted the drill and began to drill again, the drill bit sheared apart.Most of the fragments were retrieved; however, one fragment remained.The surgeon decided to leave the fragment as is.The fragment was approx.1cm in length.X-rays were taken were but are not available.A second st6100, standard procedure pack, was opened and the 3.2mm drill was used to complete the case with no other 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: 7922712
• Report Number: 1220246-2018-00678
• Device Sequence Number: 16550404
• 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
• 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 Model Number: STANDARD PROCEDURE PACK
• Device Catalogue Number: ST6100
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other