MAUDE Adverse Event Report: ARTHREX INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-1409LP
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/30/2017
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.The device was requested for evaluation but was not returned, 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.Device history record review revealed nothing relevant to this event.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being 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 as the surgeon was performing an arthroscopic left knee acl reconstruction procedure, the head of the reamer broke as it was being started.The head of the reamer was in contact with the patient's bone and broke into three pieces - shaft and two blades.One of the blades was embedded into the bone and the other was lost from view.The sales rep suggested to check the posterior compartment and a basic examination was carried out.The surgeon was unconcerned, however, requested an x-ray be taken whilst in recovery.Follow-up investigation: device is not available for return as it was kept by the hospital in a sharps container and cannot be retrieved.The third piece of the device was left in the posterior compartment of the patient's joint.An image intensifier was used to locate the fragments and therefore a picture is unable to be provided.

• Brand Name: REAMER, LOW PROFILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7048070
• Report Number: 1220246-2017-00444
• Device Sequence Number: 1629795
• Product Code: LXH
• UDI-Device Identifier: 00888867016767
• UDI-Public: 00888867016767
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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: 11/01/2021
• Device Catalogue Number: AR-1409LP
• Device Lot Number: 10082087
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/21/2017
• 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