MAUDE Adverse Event Report: NOVASSTEP ARCAD; STAPLE

Model Number	ARCAD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint # (b)(4) opened : all investigation done at this time confirmed these batches of arcad were produced and controlled conform to novastep specifications.Comment: 2 staples have been used for this case, we don't know which staple lot number has broken.For information, we add in this mdr all information related the 2nd staple.Model # catalog # : cs041618, lot # : d00213, expiry date : 02/01/2016.Device evaluated by manufacturer ? not explanted.Device not explanted.
Event or Problem Description
During a sales rep visit on (b)(6) 2016 it was reported to novastep sales rep.That during the last 12 month 3 cases have conducted to arcad 18 compressive staple breakage.This is the same surgeon for these 3 cases.First case: arcad 18-16-18 compressive staple was detected as broken by the surgeon during the analysis of xray performed during a patient follow up visit.The surgeon expects that the use of only two arcad 18 staples to proceed mtp arthrodesis to be too weak.Assembly should have been done using bigger staples or additional devices associated with two arcad 18 compressive staples.The others 2 cases have been reported in report 3010673777-2016-00001, 3010673777-2016-00002.

• Brand Name: ARCAD
• Common Device Name: STAPLE
• Manufacturer (Section D): NOVASSTEP; espace performance alphasis; bâtiment p; saint -grégoire, 35769 ; FR 35769
• MDR Report Key: 6053719
• Report Number: 3010673777-2016-00003
• Device Sequence Number: 1837634
• Product Code: JDR
• UDI-Device Identifier: 03700879501291
• UDI-Public: 03700879501291
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: 01/11/2016
• Device Model Number: ARCAD
• Device Catalogue Number: CS041618
• Device Lot Number: C00684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2016
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other