MAUDE Adverse Event Report: NOVASTEP S.A.S PECA3; OSTEOSYNTHESIS STERILE SCREW

Model Number	PECA3
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer complaint from a portuguese client: during the surgical operation, the surgeon noticed that the screw length did not match the label.After investigation, we found that a mix-up between 2 screw lengths had been created during their manufacture.Following the traceability exercise carried out, we confirm that only 16 screws were sent to our customers, but no screws were sent to the usa.All nc screws have been quarantined at our customers' premises; these screws will be replaced.Our internal stocks are secure.Our analysis is ijn progress to identify the root cause and implement the action plan to eradicate this defect.
Event or Problem Description
Currently on a surgery of doctor, we opened an implant peca size 42 and 3.0.But the implant in the box is wrongly packaged and is actually a 30.

• Brand Name: PECA3
• Common Device Name: OSTEOSYNTHESIS STERILE SCREW
• Manufacturer (Section D): NOVASTEP S.A.S; allée jacques frimot; rennes, 35000 ; FR 35000
• Manufacturer (Section G): NOVASTEP S.A.S; allée jacques frimot; rennes, 35000 ; FR 35000
• Manufacturer Contact: patrick patrick ; 2 allée jacques frimot; rennes, 35000 ; FR 35000
• MDR Report Key: 21864653
• Report Number: 3010673777-2025-00006
• Device Sequence Number: 7917022
• Product Code: HWC
• UDI-Device Identifier: 03700879510200
• UDI-Public: 03700879510200
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K143229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/10/2025

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
• Device Model Number: PECA3
• Device Catalogue Number: PS020042
• Device Lot Number: L21731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown