MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ULTRA 360 PATIENT POSITIONING SYSTEM; BASE UNITS AND ADAPTERS

Model Number	A2009
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.The ultra 360 patient positioning system ( a2009) was returned for evaluation.The reported complaint was confirmed.Unit was received with the std.Adaptor and not the tri-star adaptor and showing signs of routine wear.The handles were out of adjustment and not holding properly and both shock cushion were worn, requiring replacement.General maintenance and cleaning also required.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
A facility reported that the top locking handle on the ultra 360 patient positioning system (a2009) would not lock; it moves even when locked and the gold locking handle was very loose.It is unknown if there was patient involvement however; no patient injury was reported or surgical delay has been reported.

• Brand Name: ULTRA 360 PATIENT POSITIONING SYSTEM
• Common Device Name: BASE UNITS AND ADAPTERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 12186176
• Report Number: 3004608878-2021-00468
• Device Sequence Number: 1492467
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1