MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES CUSHING IVD - UP - 9 INCHES - 1.5MM X 10; N/A

Catalog Number	RN5981
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/05/2024
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
It was reported that during an orthopedic spine procedure, the tip of the biting portion of the ruggles cushing ivd up 9 inches 1.5mm x 10 (rn5981) broke off and lodged in the disk space of the patient's spine.After the the breakage, staff "removed the device from the field and attempted to remove broken piece with other instruments, suction, and magnet." it was reported that there was approximately "20 minutes of actively attempting to remove broken piece of instrument from patient." they were not able to retrieve the piece safely, so the surgeon made the decision to leave the broken piece in the disk space.No further intervention were performed after the initial removal attempts during surgery.
Additional Manufacturer Narrative
The ruggles cushing ivd (b)(6) was returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.Failure analysis: visual evaluation of the ruggles cushing ivd found that the device was is in used condition with wear and scratching on the surface.The upper jaw was broken off at the hinge.The product lot number indicates a manufacture date of 2020 and the provided sales order# identified that this product was sent to the customer in 2021.Breakage of the jaw may be the result of wear or rough handling over multiple years of use.Root cause analysis: the reported complaint was confirmed.The returned ruggles cushing rongeur was in used condition with the jaw broken off due to wear or rough handling.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: RUGGLES CUSHING IVD - UP - 9 INCHES - 1.5MM X 10
• 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: 20895906
• Report Number: 3014334038-2024-00221
• Device Sequence Number: 18118407
• Product Code: HTX
• UDI-Device Identifier: 10381780231998
• UDI-Public: 10381780231998
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: RN5981
• Device Lot Number: AD2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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: Other
• Patient Sex: Unknown