MAUDE Adverse Event Report: ARTHREX INC. BURR, FLUSHCUT OVAL, 12 FLUTE, 5.5 MM X 13 CM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number AR-8550FOT

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

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.Complaint confirmed.The lot number was not provided therefore device history record review cannot be performed.The evaluation revealed that a portion of the returned fragment's edge was broken off.The broken surface was rough and uniform, the origin of the fragment is unknown since the outer shaft was not returned for evaluation.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 Description

It was reported that the patient had acl surgery on (b)(6) 2017 and the surgery was successful.One week post op x-rays were taken.The x-rays revealed a metal fragment in the posterior aspect of the knee in the soft tissue.The decision was made to leave the fragment.One month later during a routine recheck x-rays were taken to evaluate the metal fragment and it had migrated to the anterior portion of the knee.The surgeon was concerned that the fragment could cause damage in the area that it was in and decided to remove it.On (b)(6) 2017 the patient had a second surgery to remove the metal fragment.Upon removal of the fragment it appeared to be a piece off a shaver blade used during the original surgery.Patient was male (b)(6) years old.

• Brand Name: BURR, FLUSHCUT OVAL, 12 FLUTE, 5.5 MM X 13 CM
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 6934417
• MDR Text Key: 89178916
• Report Number: 1220246-2017-00376
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-8550FOT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR