MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE OSTEOTOME SHORT 5 MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-13203-05
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/12/2016
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.An evaluation of the device cannot be performed as the device was not returned.To the manufacturer.Should additional information become available it will be reported in a supplemental report.Lot number was not provided so device history record review cannot be performed.The cause of the event could not be determined from the information available and without device evaluation.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.Unknown device disposition.
Event or Problem Description
It was reported that a small shard of osteotome broke-off during osteotomy procedure at lateral edge of osteotomy.Surgeon was unable to locate the fragment so it was left in situ as it is in a non-critical place within osteotomy.

• Brand Name: LOW PROFILE OSTEOTOME SHORT 5 MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6411452
• Report Number: 1220246-2017-00069
• Device Sequence Number: 16394460
• Product Code: MDM
• UDI-Device Identifier: 00888867009783
• UDI-Public: 00888867009783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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 Catalogue Number: AR-13203-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/16/2017
• 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