MAUDE Adverse Event Report: ARTHREX, INC. POWERASP, 5.5MM X 13CM; ACCESSORIES,ARTHROSCOPIC

Catalog Number AR-8550PR

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2016

Event Type  Injury  

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 or excessive bending forces being applied during use.This is the first complaint of this type for this part/lot combination.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.

Event Description

It was originally reported that metal shavings were produced form the 5.5mm powerasp while it was being used.Follow-up investigation: the powerasp was used for a shoulder acromial decompression procedure.The device produced metal shavings during use.The suction from the shaver device was used to remove the shavings; however it was unable to be confirmed if all pieces were removed from the joint.The case was completed at this point, and there was no further issue to the patient.Device was discarded by the facility.

• Brand Name: POWERASP, 5.5MM X 13CM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337017
• MDR Report Key: 5441781
• MDR Text Key: 38390601
• Report Number: 1220246-2016-00049
• Device Sequence Number: 1
• 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: 01/25/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: AR-8550PR
• Device Lot Number: 10019989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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