MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS 3711063 GIRAFFE 90DEG VERT; PFM11

Model Number	3711063
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 is 2 of 2 reports linked to mfg report number 3003249645-2022-00016: it has been reported that the forceps 3711063 giraffe was not suitable to ensure complete sterilization.The facility has not reported if there was patient involvement, injury or surgical delay related to this event.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The giraffe forceps (3711063) was returned for evaluation.Device history record (dhr): the dhr was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the giraffe forceps identified that the finishing of the welding was not good; there was roughness.The strength of the welding was compliant; there was no risk of breakage.Root cause: it was determined that the issue was due to an improper finishing of the welding during the manufacturing operations.An awareness has been performed to the operators.No risk for the patient, the defect is visual and was discovered before the use of the device.

• Brand Name: FORCEPS 3711063 GIRAFFE 90DEG VERT
• Common Device Name: PFM11
• 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 ; 6099362319
• MDR Report Key: 14240394
• Report Number: 3003249645-2022-00017
• Device Sequence Number: 4736462
• Product Code: KAE
• UDI-Device Identifier: 10381780076100
• UDI-Public: 10381780076100
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 3711063
• Device Catalogue Number: 3711063
• Device Lot Number: 6022014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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