MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HANDLE CEV6285R DIA 5MM STR W/RATCHET; PFM16

Catalog Number	CEV6285R
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 5mm dia str handle w/ratchet (cev6285r) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Evaluation of the handle verified the complaint reported by the customer as valid.The two handles were hard to use.It was determined that the pin has been too dull.It was noted that this was an isolated occurrence and a reminder has since been sent to the operators.
Event or Problem Description
It was reported that the forceps/5mm dia str handle w/ratchet (cev6285r) does not open properly, despite lubrication.The device was used on a patient.There was no injury; however, surgery time was increased superior to 30 minutes.Another instrument was used to complete the procedure.

• Brand Name: HANDLE CEV6285R DIA 5MM STR W/RATCHET
• 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: 21093311
• Report Number: 3003249645-2024-00061
• Device Sequence Number: 21125027
• Product Code: HET
• UDI-Device Identifier: 10381780094609
• UDI-Public: 10381780094609
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: CEV6285R
• Device Lot Number: 7351417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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