MAUDE Adverse Event Report: ARTHREX, INC. MULTIFIRE FASTPASS SCORP; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-13997MF

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/15/2015

Event Type  Injury  

Event Description

It was reported that the event occurred during the repair procedure.While pulling the tendon laterally, the tip of the multifire fastpass scorpion broke in the soft part of the patient.They tried to retrieve the broken piece but it is stuck and lost in the soft tissue.Surgery was finished without any further incident.

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.The device was requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.This type of event is typically caused by user mechanical damage from dropping the device or hitting the device against bone or another device.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device expected but not yet returned.

• Brand Name: MULTIFIRE FASTPASS SCORP
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4953905
• MDR Text Key: 20808972
• Report Number: 1220246-2015-00201
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/16/2015

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 Catalogue Number: AR-13997MF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other