MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD KNIFE #3 HANDLE MATTE; N/A

Catalog Number	110175
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the knife #3 handle matte (110175) was unacceptable because the stamp was too deep; unable to clean it up and can't go through the autoclave.No patient injury, death or surgical delay has been reported.
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.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: visual evaluation noted the knife handles were received in unused condition in their original packaging with no visible defect.The product grips, "#3" stamp and ruler etchings all had the intended appearance and the product was within specifications.Root cause analysis: : the reported complaint could not be duplicated.The returned product had the expected appearance and no abnormalities were identified.This complaint may be the result of customer preference.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Updated fields: b5, g3, g6, h2, h3, h10 b5/additional information: it was later reported that the alleged product problem was discovered during inspection; thus, there was no patient involvement.

• Brand Name: KNIFE #3 HANDLE MATTE
• Common Device Name: N/A
• 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: 17991919
• Report Number: 3014334038-2023-00166
• Device Sequence Number: 15172897
• Product Code: GDZ
• UDI-Device Identifier: 10381780433101
• UDI-Public: 10381780433101
• 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,Followup,Followup
• Report Date (Section B): 12/20/2023

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: Other
• Device Catalogue Number: 110175
• Device Lot Number: AF2308
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 11/28/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/13/2023; 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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