MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) MAYFIELD ULTRA BASE UNIT; BASE UNITS AND ADAPTERS

Model Number	A1114A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the transitional on the mayfield ultra base unit (a2101) is stuck in place due to hole being deformed.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
The mayfield ultra base unit (a2101) 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 handle closed without the transitional being inserted.This caused the handle to become misshaped.The handle was reopened to accept the new transitional, and the 6in transitional was replaced due to worn teeth.Shock cushion, finishing cap and adjustment wrench was replaced due to wear.General cleaning and maintenance required at this moment.Root cause - the reported complaint was confirmed from the evaluation.Unit received had the handle closed without the transitional being inserted.Evaluation showed that the 6in transitional teeth, shock cushion, finishing cap and adjustment wrench are worn.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: MAYFIELD ULTRA BASE UNIT
• Common Device Name: BASE UNITS AND ADAPTERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12846119
• Report Number: 3004608878-2021-00637
• Device Sequence Number: 4292753
• Product Code: FWZ
• UDI-Device Identifier: 10381780253556
• UDI-Public: 10381780253556
• 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): 11/19/2021

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: A1114A
• Device Catalogue Number: A2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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