MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION IE006 49 28 TRIAL LINER; TEMPLATE FOR CLINICAL USE

Catalog Number	RA90190706
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Trial liner broke in pieces during surgery.Part pieces in the patient.

• Brand Name: IE006 49 28 TRIAL LINER
• Common Device Name: TEMPLATE FOR CLINICAL USE
• Manufacturer (Section D): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer (Section G): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer Contact: jean-denys marechal ; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150 ; 472056010
• MDR Report Key: 23411658
• Report Number: 3008668801-2025-00161
• Device Sequence Number: 10269420
• Product Code: HWT
• UDI-Device Identifier: 03662200012824
• UDI-Public: 03662200012824
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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 Catalogue Number: RA90190706
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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