MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD IRIS SCISSORS STRAIGHT 4 1/2, 25/BOX; INSTRDEFLTDEFLT

Catalog Number	5-304-ST-25
Medical Device Problem Codes	Material Frayed (1262); Mechanical Jam (2983)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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
A facility reported that the iris scissors straight 4 1/2, 25/box (5-304-st-25) were unable to cut sutures.It was conveyed that the handles were too tight to move, and the tips were dull, which resulted in small redness and discomfort for the patient.No death or surgical delay reported.
Additional Manufacturer Narrative
Updated fields: d9, g3.G6, h2, h3, h6, h11.The iris scissors straight 4 1/2, 25/box (5-304-st-25) was not returned for evaluation after three good faith attempts (gfes) were made.The lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.The definite root cause cannot be determined.The issue of being tight and dull may be the result of damage or customer preference.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: IRIS SCISSORS STRAIGHT 4 1/2, 25/BOX
• Common Device Name: INSTRDEFLTDEFLT
• 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: 22686958
• Report Number: 3014334038-2025-00111
• Device Sequence Number: 18360307
• Product Code: HNF
• UDI-Device Identifier: G165SU71055110
• UDI-Public: G165SU71055110
• 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
• Report Date (Section B): 09/03/2025

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: 5-304-ST-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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