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

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
Event or Problem Description
It was reported that the tolerances on the mayfield ultra 360 patient positioning system (a2009) was off and the unit was slipping.The facility has not reported if there was patient involvement, injury or surgical delay relative to this event.
Additional Manufacturer Narrative
The ultra 360 patient positioning system (a2009) was returned for evaluation: failure analysis: the unit was received with an extra upper handle assembly from another unit.The extra upper handle will be returned to the customer unrepaired.Unit received had the upper and lower handles adjusted to bring them back into tolerance from not holding properly.Both shock cushions, ¼ inch pin, and adjustment wrench were replaced from being worn.Unit was received without the standard adaptor and tri-star adaptor.The unit was tested with a new standard adapter, but will be returned to the customer with the handle open.Root cause analysis: complaint has been confirmed via inspection of the unit.However, service & repairs could not duplicate slipping, but found that the handles were out of adjustment and not holding properly.The handles required readjustment and the unit required replacement of worn components.Probable root cause is routine use and wear.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2011).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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
• 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: 14627930
• Report Number: 3004608878-2022-00120
• Device Sequence Number: 14721980
• 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
• Report Date (Section B): 06/07/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/07/2022
• 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