MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD GOLDMAN-FOX WOUND SCS, 5; PFM12

Catalog Number	100-9837
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The goldman-fox wound scissor, 5 (100-9837) was not returned to the manufacturer, as the customer indicated the product was disposed of; therefore, an evaluation of the device could not be performed.A definitive root cause cannot be determined.The issue of breaking may be the result of rough handling or corrosion.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
A facility reported that while using the goldman-fox wound scissor, 5 (100-9837), the tip broke off in the patient's mouth.The facility reported that the patient is okay, and there was no serious injury or medical attention required." staff was able to get the tip out of the mouth safely and it was not swallowed.The item was discarded by the facility.The total uses of the scissor prior to breakage were unknown.No injury, death or surgical delay was reported.

• Brand Name: GOLDMAN-FOX WOUND SCS, 5
• Common Device Name: PFM12
• 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: 22391717
• Report Number: 3014334038-2025-00091
• Device Sequence Number: 9180287
• Product Code: LRW
• UDI-Device Identifier: 10381780501459
• UDI-Public: 10381780501459
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: 100-9837
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 07/02/2025
• 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