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

Catalog Number	¿A3101¿
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional 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 3004608878-2024-00048: a facility reported that during use of the mayfield composite series base unit (a3101) for a nuero case, slippage occurred.No information on patient injury or surgical delay has been provided.Additional information has been requested.
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 showed that the handle tested low when put under pressure, the stud on the swivel adapter is bent, the drawbar and viton ball are worn, and the teeth on the swivel sleeve and the transitional are worn.All worn components were replaced with new parts, and general cleaning and maintenance were performed.Additionally, as a precaution, the unit was sent to quality engineering (qe) for further investigation.Qe confirmed the findings of the service & repair report with no additional device deficiencies observed.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause is routine use and 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 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 08540 ; 6099362319
• MDR Report Key: 19090534
• Report Number: 3004608878-2024-00047
• Device Sequence Number: 7141232
• 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,Followup
• Report Date (Section B): 05/09/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: A3059 MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Patient Sex: Unknown