MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. JOHANN FENESTRATED INSERT; PFM16

Catalog Number	CEV625T1U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This complaint is 2 of 2 for the insert component reportedly used during this event and is related to mfg number 3003249645-2025-00018: it was reported that "during an operation, the surgeon noticed a loss of grip, making it impossible to resume gripping due to the absence of one of the fenestrated paddles".It was subsequently reported that the fragment of the johann fenestrated insert (cev625t1u) fell into the patient's abdomen.It was confirmed that all pieces were retrieved without any consequences to the patient.; no x-ray was required.It was reported that another forceps was used to finalize the surgery.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The johann fenestrated insert (cev625t1u) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation verified the problem statement as valid.The fixed jaw was broken, and the wire was bent.The breakage area showed a corroded area that suggested a crack prior to the breakage.The material of a part of the breakage area was not homogeneous.The jaws were provided by an approved supplier.The reception control of the jaws batch number was performed in july 2019 and was compliant.Additionally, the composition of the materiel was compliant.Root cause analysis: at this stage, a specific root cause could not be confirmed; however, potential root causes are as follows: wear due to the age of the instrument.The instrument is six years old, and the repetitive reprocessing 150 cycles could lead to a breakage.Poor repetitive handling conditions (force, thrown instrument).The instrument should be handled with care and stored in a clean, dry place.Another potential root cause could be the composition of the raw material or a defect in during forging of the raw material.By reviewing the documentation, we did not observe any evidence of this root cause.
Event or Problem Description
N/a.

• Brand Name: JOHANN FENESTRATED INSERT
• Common Device Name: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21976102
• Report Number: 3003249645-2025-00017
• Device Sequence Number: 7265091
• Product Code: GCJ
• UDI-Device Identifier: 10381780428664
• UDI-Public: 10381780428664
• Combination Product (Y/N): N
• PMA/510(K) Number: K080257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: CEV625T1U
• Device Lot Number: 4184880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown