MAUDE Adverse Event Report: SPINEART SA FINAL TIGHTENER PERLA TL

Model Number	TLF-IN 05 41-N
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
On 10.Oct.2024, we received a complaint from france registered under cpt-3260, reporting that during a surgery on (b)(6) 2024, when using the final tightener instrument reference tlf-in 05 41-n, batch number 6-8534/001, water leaked into the patient.The surgeon completed the surgery by using another instrument.The surgical site was washed with betadine serum (the patient is under systematic preoperative antibiotic treatment).The patient is fine and he left the hospital with no prolonged hospitalization.
Additional Manufacturer Narrative
After receiving the complaint, the manufacturing folder has been reviewed.The analysis of the manufacturing documents and control quality documents detected that the raw materials, production processes and finished products were conforming to the specifications.Complained instrument belongs to a batch (b)(4) units, manufactured on march 2023 and this is the first complaint we receive for this type of defect for this batch.We received the involved instrument, and it was sent to our subcontractor for investigation.Considering the nature of the issue reported in this complaint, it was decided to activate our internal corrective action preventive action (capa) process and the capa-1354 has been opened accordingly.The investigation on the possible root causes performed in the context of this capa, concluded that in some very rare cases of dimensional variations, some residues of moisture generated during the cleaning and/or sterilization process, may enter in the capsule underneath the handle.It was therefore decided to improve the design of this capsule to ensure a perfect tightness during cleaning and sterilization processes.
Event or Problem Description
On 10.Oct.2024, we received a complaint from france registered under cpt-3260, reporting that during a surgery on (b)(6) 2024, when using the final tightener instrument reference tlf-in 05 41-n, batch number 6-8534/001, water leaked into the patient.The surgeon completed the surgery by using another instrument.The surgical site was washed with betadine serum (the patient is under systematic preoperative antibiotic treatment).The patient is fine and he left the hospital with no prolonged hospitalization.

• Brand Name: FINAL TIGHTENER PERLA TL
• Common Device Name: FINAL TIGHTENER PERLA TL
• Manufacturer (Section D): SPINEART SA; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer Contact: laure-allison verboux ; chemin du pré fleuri 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 20586640
• Report Number: 3007728266-2024-00016
• Device Sequence Number: 8787583
• Product Code: HXX
• UDI-Device Identifier: 07640450868954
• UDI-Public: 07640450868954
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: TLF-IN 05 41-N
• Device Catalogue Number: TLF-IN 05 41-N
• Device Lot Number: 6-8534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female