MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ¿MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD¿; ¿COMPOSITE SERIES¿

Model Number	A3101
Medical Device Problem Code	Mechanical Problem (1384)
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 arm on the mayfield composite series base unit a3101 was not secured and came unbolted during an unspecified procedure.No patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
Mayfield composite series base unit, standard (a3101) 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 showed that the handle tested low under pressure, but that would not cause it to come unbolted.As a result, the handle was readjusted.Additionally, the drawbar and viton ball were replaced in the swivel adapter due to wear.General maintenance and cleaning has been performed.Root cause - the complaint is not confirmed, as no issues were observed relative to the reported complaint.Probable root cause of the customer reported issue is improper setup of the mayfield system.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 COMPOSITE SERIES BASE UNIT, STANDARD¿
• Common Device Name: ¿COMPOSITE SERIES¿
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16337766
• Report Number: 3004608878-2023-00018
• Device Sequence Number: 6845150
• Product Code: FWZ
• UDI-Device Identifier: 10381780268161
• UDI-Public: 10381780268161
• 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): 02/09/2023

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: A3101
• Device Catalogue Number: ¿A3101¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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