MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ULTRA 360 PATIENT POSITIONING SYSTEM; N/A

Catalog Number	A2009
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during an unspecified neuro case, the ultra 360 patient positioning system (a2009) was used, and there was a slip of the arm when the patient was pinned.No delay nor patient injury was reported.
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.
Additional Manufacturer Narrative
Additional information was received indicating the following: 1.Was there a delay in surgery due to product problem? if yes, how long? 5-10 minute delay.We had to remove the positioner from the bed and replace it with another 360 attachment.2.When placing the skull clamp, if you were to draw an imaginary line between the single pin and the rocker arm swivel point, did that imaginary line pass through an axial center of the skull? there was not an issue with the skull clamp.The clamp that was on the patient remained and the 360 arm/bed piece was changed out.After the surgeon applied the skull clamp, we attached the 360 arm (that was attached to the bed).When the patient was locked into place we went to register the patient to the navigation and noticed the arm started drifting downward.With gentle pressure applied to the skull clamp the whole arm drifted downward.There was no defect with the skull clamp, the defect is with the locking mechanism on the 360 arm.3.Did each pin engage the cranium in a perpendicular approach? the skull clamp was applied appropriately.Investigation findings: the ultra 360 patient positioning system (a2009) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - unit received had the upper handle upper assembly replaced due to damage caused by customer usage.The upper handle was recently replaced on a previous service request.The shock cushion in the lower handle will be replaced due to slight wear.The unit was received without the standard adapter.Due to the upper handle assembly having damage, it is believed that the standard adapter dongle has damage done to it as well.General cleaning and maintenance will be performed as well.Root cause - the reported complaint is confirmed via inspection of the unit.The upper handle assembly has been damaged by customer usage.The upper handle will require replacement due to the damage.Probable root cause is rough or improper handling of the unit.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: ULTRA 360 PATIENT POSITIONING SYSTEM
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18062398
• Report Number: 3004608878-2023-00195
• Device Sequence Number: 15319887
• Product Code: FWZ
• UDI-Device Identifier: 10381780267850
• UDI-Public: 10381780267850
• 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): 12/06/2023

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: A2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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