MAUDE Adverse Event Report: ARTHREX, INC. SMALL STAPLE, 8MM, SS; STAPLE, FIXATION, BONE

Catalog Number AR-8708

Device Problem Difficult to Insert (1316)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/01/2015

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.This is the first complaint of it's kind for this device.The quickfix staple is a very small staple and if the proper size staple was used, this device does not require excessive force to insert.Several guidewire sizes are provided to assist in proper bone prep prior to inserting the staples.If the surgeon was experiencing a lot of force to insert, per the surgical technique, a larger guidewire size should have been used.A most likely cause of the event is improper bone prep.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.Part remained in the patient.

Event Description

It was reported that when the quickfix staple was used for an akin osteotomy, the lateral cortex broke on insertion of the staple.They used another staple to fix the lateral cortex.

• Brand Name: SMALL STAPLE, 8MM, SS
• Type of Device: STAPLE, FIXATION, BONE
• 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 ; 8009337001
• MDR Report Key: 5146756
• MDR Text Key: 28142001
• Report Number: 1220246-2015-00269
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-8708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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