MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES DECKER IVD UP 6 INCHES 1.5MM X 5MM; RONGEURS/KERRISONS/IVDS

Catalog Number	RN7130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
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 the tip of the ruggles decker ivd up 6 inches 1.5mm x 5mm (rn7130) broke off inside a patient during spinal surgery as the physician was using it to dissect.The surgical team was reportedly confident that they retrieved the broken piece from the instrument and assumed there was no patient harm.No surgical delay has been reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The ruggles decker ivd up (rn7130) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.A definitive root cause could not be determined.The issue of breaking during use may be the result of rough handling or environmental damage.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.

• Brand Name: RUGGLES DECKER IVD UP 6 INCHES 1.5MM X 5MM
• Common Device Name: RONGEURS/KERRISONS/IVDS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17761285
• Report Number: 3014334038-2023-00153
• Device Sequence Number: 7172498
• Product Code: HTX
• UDI-Device Identifier: 10381780434962
• UDI-Public: 10381780434962
• 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,Followup
• Report Date (Section B): 10/19/2023

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: RN7130
• Device Lot Number: AJ2212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/19/2023
• Date Device Manufactured: 12/01/2022
• 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