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

Catalog Number	A2101
Medical Device Problem Code	Degraded (1153)
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
This is 1 of 2 reports linked to mfg report number 3004608878-2025-00056: a facility reported that the mayfield ultra base unit (a2101) was non-usable; the transition member has damaged thread and star-shaped teeth was flat.This was discovered before an unspecified surgery and this issue increase the surgery time for more than 30 minutes.It was also necessary to change the approach of the operation.
Additional Manufacturer Narrative
The mayfield ultra base unit (a2101) was returned for evaluation: failure analysis - the investigation of the returned unit shows that the 6-inch transitional member has damaged the inner thread in the center of its starburst.The starburst teeth have become flat, and must be replaced to be locked to a swivel adapter unit properly.The adjusting wrench thread is broken and rusty, and the wrench needs to be replaced.The left bracket was fixed to tight onto the connection tube, and the dowel pin which fixates the bracket is deformed and the left bracket must be opened by removing the finishing cap.The handle assembly's shock cushion and the cam link support pin were removed and must be replaced.To resolve all issues, the adjustment was replaced, the left bracket was overhauled, the transitional member was replaced and marked, the base handle assembly¿s shock cushion and its cam link support pin were replaced, 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 a function test.Root cause - the complaint is confirmed via inspection of the unit.The probable root cause is improper handling and routine wear of the unit.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: 21657302
• Report Number: 3004608878-2025-00055
• Device Sequence Number: 7547405
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/21/2025
• 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: A1018 MAYFIELD SWIVEL ADAPTOR.
• Patient Sex: Unknown