MAUDE Adverse Event Report: NOVASTEP ARCAD EXPRESS; STAPLE

Model Number	STAPLE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional 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°180011 ; 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).
Event or Problem Description
Two staples (139-15-1414-s, lot number 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
• Common Device Name: STAPLE
• Manufacturer (Section D): NOVASTEP; espace performance alphasis; bâtiment p; saint-grégoire,
• MDR Report Key: 8733756
• Report Number: 3010673777-2019-20012
• Device Sequence Number: 16672993
• Product Code: JDR
• UDI-Device Identifier: 03700879502328
• UDI-Public: 03700879502328
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 01/04/2023
• Device Model Number: STAPLE
• Device Catalogue Number: 139-15-1414-S
• Device Lot Number: 180011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR