MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VARADY PHLEB LGE HK/SPATU 7 IN DE EXTRACTOR; JARIT

Catalog Number	X21417
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The varady phleb lge hk/spatu 7 in de extractor (x21417) was not returned for evaluation, as the customer stated the product was disposed of.Lot number was provided, device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.Customer provided a photo of the instrument.Per the provided image, it was determined that the tip breakage may have resulted from environmental damage or rough handling.However, a definitive root cause cannot be determined without return of the actual product for evaluation.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
A facility reported that the tip of the varady phleb lge hk/spatu 7 in de extractor (x21417) broke off in a patient while pulling on a vein, during vascular surgery.An x-ray was taken to retrieve the broken part.It was reported that the patient was in good condition.Another device was available for use.There was a delay in surgery of approximately 20-30 minutes.

• Brand Name: VARADY PHLEB LGE HK/SPATU 7 IN DE EXTRACTOR
• Common Device Name: JARIT
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18312368
• Report Number: 3014334038-2023-00185
• Device Sequence Number: 20512914
• Product Code: GAI
• UDI-Device Identifier: 10381780373582
• UDI-Public: 10381780373582
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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 Expiration Date: 06/01/2023
• Device Catalogue Number: X21417
• Device Lot Number: AC2306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/12/2023
• Date Device Manufactured: 06/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown