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

Catalog Number	A2101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report is 3 of 3 and linked to mfg report numbers 3004608878-2025-00044 and 3004608878-2025-00049: a facility reported that the mayfield ultra base unit (a2101) is mobile when it should not be - tightening problem.The issue was noted before surgery while the patient was under anesthesia.There was no patient injury and no increased surgery time.
Additional Manufacturer Narrative
The mayfield modified 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 - investigation of the returned unit shows that the 6-inch transitional member has damaged starburst teeth, the adjusting wrench thread is broken, and the wrench needs to be replaced.Additionally, the handle assembly's shock cushion and the cam link support pin were removed and must be replaced.To resolve all issues, the following were replaced: the transitional member; the adjustment wrench; the base handle assembly¿s shock cushion and its cam link support pin; and the handle assembly was reassembled and adjusted to build up the required pressure onto the transitional member.After completing the repair, the unit successfully passed the function test.Root cause - the complaint is confirmed via inspection of the unit.The probable root cause is mishandling and improper disassembly of the unit.Additionally, this unit is beyond integra¿s 7 years recommended life cycle (manufactured in 2007).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.At present, we consider this complaint to be closed.

• 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: 21602011
• Report Number: 3004608878-2025-00050
• Device Sequence Number: 17251052
• Product Code: HBM
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: A1059 MAYFIELD SKULL CLAMP; A1064 MAYFIELD BALL SOCKET SWIVEL ADAPTOR
• Patient Sex: Unknown