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

Model Number	A2009
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
A facility reported that the ultra 360 patient positioning system (a2009) tolerances are off and slipping.The facility has not reported if there was patient involvement, injury or surgical delay relative to this event.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The ultra 360 patient positioning system (a2009) was returned for evaluation: failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The lower handle lower assembly was replaced due to it having slippage.An extra 41a1636 upper handle assembly was sent in with the unit.No maintenance will be performed on the extra upper handle assembly.The unit was shipped without the standard adaptor or the tri-star adaptor.General cleaning and maintenance performed and all worn components were replaced.Root cause - complaint confirmed via inspection of the unit.The lower handle lower assembly was slipping and was replaced.Probable root cause includes improper adjustment or improper handling.No adverse trends were identified.This will be monitored and trended going forward.

• 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: 14861701
• Report Number: 3004608878-2022-00136
• Device Sequence Number: 5195606
• 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): 07/07/2022

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: A2009
• Device Catalogue Number: A2009
• Device Lot Number: 111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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