MAUDE Adverse Event Report: NOVASTEP EXPRESS COMPRESSION STAPLE

Model Number 139-15-1414-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/27/2015

Event Type  Injury  

Event Description

It was reported to extremity medical in (b)(6) that the patient's bone fractured while the surgeon was temping in the staple (base wedge osteotomy).The surgeon noted that the patient had poor bone quality and this led to the fracture.There was not a device malfunction.

• Brand Name: EXPRESS COMPRESSION STAPLE
• Type of Device: COMPRESSION STAPLE
• Manufacturer (Section D): NOVASTEP; espace performance alphasis; batiment c1-c2; saint gregoire, bretagne 35769 ; FR 35769
• Manufacturer (Section G): NOVASTEP; espace performance alphasis; batiment c1-c2; saint gregoire 35769 ; FR 35769
• Manufacturer Contact: giles audic ; espace performance alphasis; batiment c1-c2; saint gregoire, bretagne 35769 ; FR 35769 ; 3630939608
• MDR Report Key: 5104404
• MDR Text Key: 26839336
• Report Number: 3010673777-2015-00001
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 139-15-1414-S
• Device Catalogue Number: 139-15-1414-S
• Device Lot Number: 140015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2014
• 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): Required Intervention
• Patient Age: 40 YR