MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES CUSHING IVD STRAIGHT 9 INCHES 1.5M; INSTRUMENTS- MICROSURGERY

Catalog Number	RN5980
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported via medwatch/mdr report #mw5178401: a medwatch/mdr report (#mw5178401) indicated that, during a spine surgery, the tip of a ruggles cushing ivd straight 9 inches 1.5m (rn5980) broke off within the disc space.The detached tip was successfully retrieved using a magnet, and the surgical team verified that no foreign body remained.The incident resulted in a surgical delay, though the duration was not specified.No patient injury was reported.
Additional Manufacturer Narrative
The rn5980 ruggles cushing ivd: straight: 9 inches: 1.5 m 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.There has been no return of product for evaluation; therefore, the definitive root cause cannot be determined.The issue of breaking may be due to wear or rough handling.

• Brand Name: RUGGLES CUSHING IVD STRAIGHT 9 INCHES 1.5M
• Common Device Name: INSTRUMENTS- MICROSURGERY
• 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: 23789226
• Report Number: 3014334038-2025-00153
• Device Sequence Number: 5520495
• Product Code: HTX
• UDI-Device Identifier: 10381780372868
• UDI-Public: 10381780372868
• 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
• Report Date (Section B): 12/12/2025

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: RN5980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/12/2025
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White