MAUDE Adverse Event Report: NOVASTEP S.A.S - RENNES - FRANCE PECA; EXACT T10 SCREWDRIVER

Model Number XSD04004

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

For removal procedure, novastep sas requires the use of specific devices : removal screwdrivers.They may be supplied on demand.They differs from inserting scrwdrivers especially as they have no cannula, ensuring an improved mechanical resistance that reduce risks of breakage, and a "wire" tip for removing the tissue and ease the access to the screw.According to available data, the physician did not use this device.

Event Description

Information received on 2024-03-20.Exact-t10 peca screwdriver tips broke during a hardware removal case.Details: a 3.0 peca screw was causing the patient pain.The doctor intended to remove the 3.0 and an additional 4.0 peca screw.Removal of the 3.0 screw achieved, thought to be the cause of irritation according to the doctor.Failure to remove 4.0 peca screw: the top of the xsd04004 broke, twice.Context: the 4.0 screw had a lot of bone growth around it.Screwdriver lined up perfectly with the screw.Consequences: the 4.0 screw was left in.Surgical delay of 15-20 minutes.

• Brand Name: PECA
• Type of Device: EXACT T10 SCREWDRIVER
• Manufacturer (Section D): NOVASTEP S.A.S - RENNES - FRANCE; 2 allée jacques frimot; rennes, france 35000 ; FR 35000
• Manufacturer (Section G): NOVASTEP SAS; 2, allée jacques frimot; rennes, france 35000 ; FR 35000
• Manufacturer Contact: patrick lebas ; 2, allée jacques frimot; rennes, france 35000 ; FR 35000
• MDR Report Key: 19135402
• MDR Text Key: 341424583
• Report Number: 3010673777-2024-00001
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Model Number: XSD04004
• Device Catalogue Number: XSD04004
• Device Lot Number: I03113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other