MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VANTAGE DOYEN FCPS 9 STR; M4 - ABDOMINAL

Catalog Number	V916-160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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
A facility reported that metal shavings were coming off of the 9 str vantage doyen forceps (v916-160).Metal splinters reportedly entered the user's finger when removing the product from the package.The user was able to safely remove the splinters from their finger.There was no patient involvement, and no surgical delay was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - d9, g3, g6, h2, h3, h4, h6, h11 the vantage doyen forceps 9 str (v916-160) was returned for evaluation.Failure analysis: the returned forceps were received in unused condition with no visible defect.The forceps were able to function as intended and no metal shavings were visibly coming off the item.Inspection for shavings on product at the us distribution center found no additional instances.Root cause analysis: the reported complaint could not be duplicated.No shavings were found on the returned product or inventory stock.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: VANTAGE DOYEN FCPS 9 STR
• Common Device Name: M4 - ABDOMINAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21374400
• Report Number: 3014334038-2025-00015
• Device Sequence Number: 15591030
• Product Code: HRQ
• UDI-Device Identifier: 10381780414506
• UDI-Public: 10381780414506
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: V916-160
• Device Lot Number: CV2208B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown