MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Model Number A3059

Device Problem Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The mayfield skull clamp (a3059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Upon investigation, it was confirmed that the locking knobs do not hold, and the teeth grind when rotated.Unit was also received without the 80lb torque knob.Root cause - the mayfield a3059 unit was received by service and repair in used condition, and the root cause of the movement issue was determined to be worn components due to heavy long term use.No further investigation required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

Event Description

A facility reported that the mayfield skull clamp (a3059) has a loose index locking knob, does not hold in place and does not lock.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿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: 13119474
• MDR Text Key: 284529258
• Report Number: 3004608878-2021-00721
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A3059
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1