MAUDE Adverse Event Report: IN2BONES SAS NEO SCREW; SCREW FOR PLATE FIXATION

Model Number	W27 ST014
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The batch records of the 2 screws lot have been reviewed and show no discrepancy.The 2 broken screw heads will be returned by the hospital to in2bones for investigation.The use of non-locking screws in the neoview system is recommended, on the proximal part, only in the oblong hole in order to adjust peroperatively the positioning of the plate.On the distal part, a second non-locking screw may be use for the recoil and reduction of the bone on the plate before final fixation.In all cases, it is recommended to use a maximum of 2 non-locking screws on the fiting assembly (including one in the oblong hole).In this particular case, it seems that the 2 broken non-locking screws were used for the final fixation of the proximal part of the plate, beside the oblong hole.
Event or Problem Description
Wrist surgery: the neoview plate-screw system is indicated for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius.It has been reported to in2bones that 2 non-locking screws broke when being inserted during the fixation of the proximal part of the plate.Each screw body remain in the patient and 2 additional screws have been implanted to secure the fixation of the proximal part of the screw.

• Brand Name: NEO SCREW
• Common Device Name: SCREW FOR PLATE FIXATION
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; ecully, 69130 ; FR 69130
• MDR Report Key: 6092815
• Report Number: 3010470577-2016-09291
• Device Sequence Number: 10933154
• Product Code: HRS
• UDI-Device Identifier: 03760225713594
• UDI-Public: 03760225713594
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: W27 ST014
• Device Lot Number: 1603020
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTHER SCREW REFERENCE W27 ST012, LOT 1512140
• Outcome Attributed to Adverse Event: Other