MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RHOTON-TYPE BALL DISS 71/2 90D TT; N/A

Catalog Number	277274TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device rhoton-type ball diss 71/2 90d tt (277274ti) was not returned for product evaluation.The customer stated the product was not available for evaluation.Evaluation and lot number information have not been provided; therefore, a review of the device history was not possible.The definitive root cause cannot be determined.The issue of breaking may result from wear or rough handling.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 the rhoton-type ball diss 71/2 90d tt (277274ti) instrument broke at a 90-degree angle at the tip and was left in the patient.According to additional information received from the sterile processing supervisor, it was noted that the neurosurgery resident and the operating room team who worked on the case stated that the broken part was not recovered, and the fluoroscopy x-ray that was performed did not detect any broken pieces.It was also conveyed that the patient was under general anesthesia during the procedure, and the operating room team tried to retrieve the broken piece after "committing a significant amount of time trying to take the broken piece out, " but it was unsuccessful.According to the neurosurgery resident, the piece might have been suctioned out when he was dissecting to remove it, and the patient was notified of the incident." a different instrument that was available was used to complete the surgery.Postoperatively, the patient had the surgery on (b)(6) 2025, was discharged on (b)(6) 2025, and had a re-admission due to a complaint of neck pain on (b)(6) 2025 and discharged on (b)(6) 2025.

• Brand Name: RHOTON-TYPE BALL DISS 71/2 90D TT
• 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: 23318716
• Report Number: 3014334038-2025-00137
• Device Sequence Number: 4989294
• Product Code: GZX
• UDI-Device Identifier: 10381780208525
• UDI-Public: 10381780208525
• 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): 10/16/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 277274TI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/16/2025
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic