MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT; BASE UNITS AND ADAPTERS

Catalog Number	A2101
Medical Device Problem Code	Mechanics Altered (2984)
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
An authorized distributor reported that during the operation, the mayfield ultra base unit (a2101) did not maintain correct tightening.Surgery time was increased for more than 30 minutes.There was no patient injury.End user hospital: (b)(6).
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The mayfield ultra base unit (a2101) was returned for evaluation: failure analysis - the reported complaint is confirmed from the evaluation.The inspection shows the handle was adjusted too easy; therefore, it cannot hold the required pressure.The shock cushion, cam support pin and set screw must be replaced because of wear, the adjusting wrench thread is broken, and the wrench needs to be replaced.The 6-inch transitional member has damaged inner threads.It must be replaced to prevent damaging and disrupting the function of the handle assembly.The left bracket is fixated to tight onto the connection tube, the dowel pin which fixates the bracket is deformed and the left bracket must be opened by removing the finishing cap.The unit has a scratched and worn off connection tube, and the unit¿s brackets were disassembled, and the handle has been removed.The connection tube must be replaced with the finishing cap and a pair of roll pins to reassemble the unit.To resolve the issues, the base unit¿s connection tube, the finishing cap, and the needed roll pins were replaced.The connection tube was drilled with the finishing cap and the right bracket.The unit was completely assembled, and the left moveable bracket was overhauled in the process.After completing the repair, the unit successfully passed a function test.Root cause - the complaint is confirmed via inspection of the unit.The probable root cause is mishandling of the unit and routine wear.Additionally, this unit is beyond integra's 7 years recommended life cycle (manufactured 2014).No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD ULTRA BASE UNIT
• Common Device Name: BASE UNITS AND ADAPTERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22296947
• Report Number: 3004608878-2025-00135
• Device Sequence Number: 12992304
• Product Code: FWZ
• UDI-Device Identifier: 10381780267997
• UDI-Public: 10381780267997
• 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: Foreign,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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 Catalogue Number: A2101
• Device Lot Number: 144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/14/2025
• 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