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

Catalog Number	¿A3101¿
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3004608878-2023-00174: a facility reported that a surgeon observed an excess movement on a mayfield composite series base unit (a3101) during an unspecified surgical procedure.No information has been provided on patient consequence or surgical delay.
Additional Manufacturer Narrative
The 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 when set up could not duplicate any movement even when put under pressure.The handle tests are all within tolerances, and the unit passed all specific functional testing.Root cause - the complaint is not confirmed.Could not duplicate movement.The unit was recently repaired and does not display any type of movement.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 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: 17881320
• Report Number: 3004608878-2023-00175
• Device Sequence Number: 15393739
• 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): 10/05/2023

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 Catalogue Number: ¿A3101¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/05/2023
• 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