MAUDE Adverse Event Report: NOVASTEP SCREWDRIVER CENTROLOCK T7

Model Number	SCREWDRIVER CENTROLOCK T7
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Description of the patient and surgery: device did not appear defective; circumstances : intraoperatively placing 2.5 locking screw into the metatarsal capital fragment.Surgeon: part of the design team.No patient data available.Description of the product : the medical device involved in this complaint is the screwdriver centrolock t7, ref.(b)(4).It's a non-cannulated screwdriver with a classical torx t7 tip.Traçabilité of the device: not communicated for the moment.Check of dhr : traceability of the broken part has not been communicated for the moment.En attente de n° de lot embout: review of historical of nc and complaint : first occurrence of such a defect.Analysis of the broken product : not returned to us conclusion: without traceability of the device and no return of the broken part, no conclusion for the moment.
Event or Problem Description
Complaint received on 2020/10/19: "broken driver while inserting a centrolock screw last week." screw driver tip sheered off whilst placing a 2.5 locking screw.The tip was left in the head of the screw and could not be retrieved.Additional data on 2020/10/20: the broken driver tip was flush with the screw, therefore was not able to remove the debris & remained in the patient.

• Brand Name: SCREWDRIVER CENTROLOCK T7
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): NOVASTEP; espace performance iii; bâtiment p; saint-grégoire, 35769 ; FR 35769
• MDR Report Key: 10836893
• Report Number: 3010673777-2020-00003
• Device Sequence Number: 4141636
• Product Code: HWE
• UDI-Device Identifier: 03700879511740
• UDI-Public: 03700879511740
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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 Model Number: SCREWDRIVER CENTROLOCK T7
• Device Catalogue Number: XSD01003
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/13/2020
• 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