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

Model Number	STANDARD PROCEDURE PACK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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 requested/is expected but has not returned for evaluation.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 fibular fracture procedure, the surgeon was attempting to attempting to fixate with a fibulock nail.Upon reaming with the 3.2 reamer, the reamer broke off into the fibular canal.He had started the reamer by hand because he was weary after the gold wire broke upon initial insertion.He then put it on power.Once on power it snapped almost instantaneously.The reamer broke right at the base of the floots.The surgeon attempted to retrieve the broken realer with various graspers but was unsuccessful.The surgeon was unable to retrieve the reamer fragment and had to leave the reamer in the fibula and plated over the top.A successful reduction and plating of fracture was completed with the broken reamer left inside bone.Additional information provided 9/11/2018: the surgeon had to make an unplanned incision to place the plate.

• 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: 7922178
• Report Number: 1220246-2018-00673
• Device Sequence Number: 1437832
• Product Code: HTW
• UDI-Device Identifier: 00816988011989
• UDI-Public: 00816988011989
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• 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