MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 BASE UNIT

Model Number	A2079
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mayfield infinity xr2 base unit (a2079) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Unit received had the shock cushion and labels on both handles replaced.The handles were readjusted to the proper pressure.Unit received with the tri-star adapter and 7¿ extension arm.Replacement of worn components and handles readjusted.General maintenance performed.Root cause analysis: complaint confirmed via inspection of the unit.The handles were readjusted to the proper pressure and the shock cushions required replacement.Probable root cause is routine use and wear.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.
Event or Problem Description
A facility reported that the mayfield infinity xr2 base unit (a2079) had too much movement.The facility has not reported if there was patient involvement, injury or surgical delay related to this event.

• Brand Name: MAYFIELD INFINITY XR2 BASE UNIT
• Common Device Name: MAYFIELD
• 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: 14240054
• Report Number: 3004608878-2022-00079
• Device Sequence Number: 5015753
• Product Code: FWZ
• UDI-Device Identifier: 10381780267959
• UDI-Public: 10381780267959
• 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): 04/28/2022

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: A2079
• Device Catalogue Number: A2079
• Device Lot Number: 189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2019
• 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