MAUDE Adverse Event Report: NOVASTEP 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
(b)(4) opened : all investigations 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 mtp arthrodesis, we don't know which staple lot number has broken in this case.For information, we add in this mdr all information related to the 2nd staple.Model # catalog # : arcad cs041818, lot # : c00554, expiry date : 09/01/2020, (b)(4), manufacturing date : 11/17/2015.Device explanted by manufacturer: not explanted.
Event or Problem Description
Hospital called novastep sales rep on 29th september 2016 and reported arcad 18 compressive staple breakage.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.Weight of the patient associated to the use of only two arcad 18 staples to proceed mtp arthrodesis (too weak) is expected to be the root cause of this breakage.Assembly should have been done using bigger staples or additional devices associated with two arcad 18 compressive staples.

• Brand Name: ARCAD
• Common Device Name: STAPLE
• Manufacturer (Section D): NOVASTEP; espace performance alphasis; bâtiment p; saint-grégoire, 35769 ; FR 35769
• MDR Report Key: 6053978
• Report Number: 3010673777-2016-00004
• Device Sequence Number: 77956
• 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: 01/11/2020
• 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
• Patient Weight: 95