MAUDE Adverse Event Report: NOVASTEP ARCAD EXPRESS; STAPLE

Model Number	STAPLE
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint (b)(4) opened.We don't have any information of the patient (age, sex, weight) and how the event occured (shock or not).Based on the reference and lot number of the broken part communicated by our customer, the dhr confirms that the part has been manufactured according to the specifications.With out the defective part, we can't perform dimensional analysis.The first investigation did not permit to conclude for this breakage.An update will be added to this report in case of we retrieve more information.Dhr review (raw material, blank parts, semi-finish and finish products): manufactured according to our specifications; xray analysis: 2 legs of the staple are broken, suggesting that a significant effort on the staple has been given; description of the bach: batch number n°150022; lot consumption: 80 parts fully sold to our customer.Analysis of the defective part: not returned.Dimensional analysis can't be perform additional test (b.17.09.266): 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 or Problem Description
Adverse event communicated by our customer : first communication the (b)(6) 2018: breakage of a staple.No reference and no lot number of the implant.Second communication the (b)(6) 2018: patient had initial surgery to correct bunion deformity.Few months later, the patient has experienced pain.After the xray, surgeon observed that the fusion was not fully done.The surgeon decided to proceed to the explantation of the staple.Reference of the staple: 139-25-2020-s; lot number: 150022.

• Brand Name: ARCAD EXPRESS
• Common Device Name: STAPLE
• Manufacturer (Section D): NOVASTEP; 30 ramland road; suite 200; orangeburg, ny 10962 NY 10962
• MDR Report Key: 8018315
• Report Number: 3010673777-2018-00003
• Device Sequence Number: 19115556
• Product Code: JDR
• UDI-Device Identifier: 03700879502366
• UDI-Public: 03700879502366
• Combination Product (Y/N): N
• PMA/510(K) Number: K142111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: STAPLE
• Device Catalogue Number: 139-25-2020-S
• Device Lot Number: 150022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention