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)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This is 1 of 2 reports linked to mfg report number 3004608878-2025-00108: a facility reported that the mayfield ultra base unit (a2101) was used in a case, and the joint could not hold.As a result, the device was changed.There was no patient injury; however, there was significant increased surgical time.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The mayfield ultra base unit (a2101) was not returned; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The definite root cause cannot be identified as the device was not returned.However, based on the reported complaint, probable root cause is routine wear or damage to the unit from misuse.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11 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 - the reported complaint is confirmed from the evaluation.The base unit was received with a loose handle, the handle needs to get overhauled and adjusted; therefore, the shock cushion, cam support pin and screw need to be replaced.The adjustment wrench is rusty and damaged, the threads and starburst teeth at the transitional member are worn off, the transitional member need to be replaced, and the isolator lock pins are damaged.To resolve all issues, all damaged and worn parts were replaced and after completing the repair, the unit successfully passed the function test.Root cause - the complaint is confirmed via inspection of the unit.The unit required replacement of worn and damaged components.The probable root cause is rough 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.

• 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: 22060296
• Report Number: 3004608878-2025-00107
• Device Sequence Number: 8328959
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 08/14/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/25/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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