MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CUSHING RONG 7 2X10MM STR; N/A

Catalog Number	280405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/03/2025
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
The following was reported via medwatch report# mw5165904: "a 2mm pituitary rongeur broke while in use, working end tip broke off into disc space.Using x-ray to identify the location, removal was attempted.Piece was unable to be removed." it was subsequently reported that there was a delay in surgery greater than 15 minutes.The surgery was "completed with the addition of attempted removal utilizing x-ray which was unsuccessful".It was reported that the patient's condition was stable following the event.
Additional Manufacturer Narrative
The cushing ronguer 7 2x10mm str (280405) was not returned for evaluation.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The issue of breaking may be the result of wear or rough handling.However, a definitive root cause cannot be determined at this time.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: CUSHING RONG 7 2X10MM STR
• Common Device Name: N/A
• 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: 21670878
• Report Number: 3014334038-2025-00036
• Device Sequence Number: 4402515
• Product Code: HTX
• UDI-Device Identifier: 10381780385783
• UDI-Public: 10381780385783
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 280405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female