MAUDE Adverse Event Report: NOVASTEP ARCAD EXPRESS; STAPLE

Model Number STAPLE

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint (b)(4) opened.We don't have any information on how the event occured (shock or not).Based on the reference and lot number of the broken parts communicated by our customer, the dhr confirms that the part has been manufactured according to the specifications.These conclusions are supported by the results obtained following the internal control of defective parts.The first investigation did not permit to conclude for this breakage.Dhr review (raw material, blank parts, semi-finish and finish products) : manufactured according to our specifications.Description of the batch : batch number n°170005 ; lot consumption: (b)(4) parts fully sold to our customer.Analysis of defective parts : conform to internal specification at least for the width of the device.Other remark: additional test ((b)(4)) : the 11th of october 2017, an tensile strength test has been performed on the smallest staple (ref arcad 10-09-09) manufactured by novastep.The parts tested were deliberately out of specifications (leg width out of spec 0.01mm).Result : according to the astm 564, 4 static points bending test was conform; 4 dynamic points bending test was conform.

Event Description

Description: two staples (139-15-1414-s, lot numbers 170005 / 180011 ) were implanted on (b)(6) 2019 for a radiolunate fusion.Both staples broke in the patient on (b)(6) 2019.The revision surgery was performed on the patient, on (b)(6) 2019.Both broken staples were returned to extremity medical for analysis.

• Brand Name: ARCAD EXPRESS
• Type of Device: STAPLE
• Manufacturer (Section D): NOVASTEP; espace performance alphasis; bâtiment p; saint-grégoire, france 35769 ; FR 35769
• Manufacturer (Section G): NOVASTEP; espace performance alphasis; bâtiment p; saint-grégoire, 35769 ; FR 35769
• Manufacturer Contact: gilles audic ; espace performance alphasis; bâtiment p; saint-grégoire, france 35769 ; FR 35769
• MDR Report Key: 8733750
• MDR Text Key: 149178009
• Report Number: 3010673777-2019-10012
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03700879502328
• UDI-Public: 03700879502328
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: STAPLE
• Device Catalogue Number: 139-15-1414-S
• Device Lot Number: 170005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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: 51 YR