MAUDE Adverse Event Report: ASST RHODENSE - OSPEDALE DI RHO NEO NON-LOCKING SCREW; SCREW FOR PLATE FIXATION

Model Number	W27 ST014 (INCLUDED IN W27 ST900)
Medical Device Problem Codes	Device Issue (2379); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In2bones has recorded 6 complaints about breakages of 8 neoview non locking screws since this screw design was put on the market (july 2015 - change control dm285/347).During the same period, (b)(4) neoview plates have been distributed worldwide, corresponding to an occurrence rate of breakage of the modified nl screws of (b)(4).Most of them were not reportable as there was no consequence for the patient, the complaints were reported to (b)(4) including one also reported to fda (manufacturer report #3010470577-2016-09291).A design change is being evaluated to strengthen the nl screws and an health hazard evaluation (ref.Fsca1706-22) is being performed as part of a corrective action plan.
Event or Problem Description
It has been reported by our distributor in (b)(6) on (b)(6) 2017: "surgery of a distal radius fracture, with neoview volar plate, ref.P30 sp210.The first intervention has been performed with this plate on a relatively simple fracture.The operative technique has been followed as indicated in the brochure.In the beginning the first screw has been positioned in the oblong proximal hole of the plate, then all the other distal screws.During the fluoroscopy check the surgeon decided to change the measure of the screw in the oblong hole (14mm), because he assessed it was too long.So he started with the removal of the inserted screw ref.W27 st014.As he engaged the screw and turned the driver backward to remove it, the screw-head broke up, leaving the screwed stem into the bone.No strength has been required for this to occur and the first screw was not even tightened totally as recommended in the technique.The surgeon tried to remove the stem with a non-invasive approach, but without any success.So he decided to leave the stem into the bone to prevent any further damage for the patient." patient outcome reported by our distributor: "- significant increase of the surgery time : addition of 20min for a surgery that usually takes around 1 hour.- no immediate consequence for the patient, but surgeon estimated that if the plate has to be removed in the future, it will take a more invasive procedure to remove the stem." additional comment from in2bones: the broken part of the screw does not have to be removed, if the patient feels no pain, the neoview system can remain implanted after bone fusion.

• Brand Name: NEO NON-LOCKING SCREW
• Common Device Name: SCREW FOR PLATE FIXATION
• Manufacturer (Section D): ASST RHODENSE - OSPEDALE DI RHO; IT
• MDR Report Key: 6706250
• Report Number: 3010470577-2017-06171
• Device Sequence Number: 1723781
• Product Code: HRS
• UDI-Device Identifier: 03760225713594
• UDI-Public: 3760225713594
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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: 12/31/2021
• Device Model Number: W27 ST014 (INCLUDED IN W27 ST900)
• Device Lot Number: 1609007B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/12/2017
• 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: Hospitalization; Other