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

Catalog Number RN7130

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

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 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 Description

N/a.

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
• Type of Device: 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
• MDR Text Key: 324060795
• Report Number: 3014334038-2023-00153
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10381780434962
• UDI-Public: 10381780434962
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RN7130
• Device Lot Number: AJ2212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2023
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1