MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE; N/A

Model Number	RN4851
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the footplate of the ruggles micro kerrison rongeur - thin footplate (rn4851) fractured off into the patient during spinal surgery.The procedure was impacted with a unspecified time delay due to the need to perform x-ray imaging to ensure that all metallic fragments were recovered from the fractured instrument.Not all broken parts were recovered but no parts were in the patient.The surgery was delayed, but no patient injury occurred.The staff used other equipment to complete the procedure.It was reported that the patient's status was stable post-procedure.
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
N/a.
Additional Manufacturer Narrative
Corrected field: d4 - serial # (lot number was incorrected reported as serial number in initial mdr).The ruggles micro kerrison rongeur - thin footplate (rn4851) was not returned for evaluation.Lot number information has been provided; 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 a broken footplate 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 MICRO KERRISON RONGEUR - THIN FOOTPLATE
• Common Device Name: N/A
• 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: 16135307
• Report Number: 3014334038-2022-00294
• Device Sequence Number: 6704074
• Product Code: HAE
• UDI-Device Identifier: 10381780141013
• UDI-Public: 10381780141013
• Combination Product (Y/N): N
• PMA/510(K) Number: K150428
• 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): 03/16/2023

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 Model Number: RN4851
• Device Catalogue Number: RN4851
• Device Lot Number: 081911A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/16/2023
• 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