MAUDE Adverse Event Report: SPINEART SA FINAL TIGHTENER PERLA TL

Model Number	TLF-IN 05 41-N
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are waiting for the return of the instrument to investigate.
Event or Problem Description
On 21.Mar.2024, we received a complaint from spain, registered under (b)(4) reporting that during a surgery on (b)(6) 2024, when using the final tightener instrument reference tlf-in 05 41-n, batch number 6-9649/051, brown water leaked into the surgical site.High risk of infection reported.The event is reported to fda because this instrument is used in the us market.
Additional Manufacturer Narrative
After we received the complaint, the manufacturing folder has been reviewed.The analysis of the manufacturing documents and control quality documents detected that raw materials and production processes were conforming to the specifications.Complained instrument belongs to a batch 55 units, manufactured on march 2023 and this is the second complaint we receive for this type of defect and for this batch.We received 2 other complaints reporting the same kind of issue for 2 others batches.We received the involved instrument, and we observed brown material on the instrument.We informed our subcontractor, and we opened the internal non-conformity nc-2164 for deeper investigation.Based on the conclusion of the previous investigation (see nc-2164) a design improvement has been decided via pcr79-26-00.
Event or Problem Description
On (b)(6) 2024, we received a complaint from spain, registered under cpt-2883, reporting that during a surgery on (b)(6) 2024, when using the final tightener instrument reference tlf-in 05 41-n, batch number 6-9649/051, brown water leaked into the surgical site.High risk of infection reported.The event is reported to fda because this instrument is used in the us market.The patient received antibiotic treatment to prevent any potential infection.No further complications.

• 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: 18986110
• Report Number: 3007728266-2024-00003
• Device Sequence Number: 16858572
• Product Code: HXX
• UDI-Device Identifier: 07640450868954
• UDI-Public: 07640450868954
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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?: 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: 6-9649
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown