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

Model Number A3059

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

The mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the unit confirmed the complaint.The unit received had movement in the rocker arm assembly.General maintenance and cleaning performed and both the disk ratchet and retainer were replaced.Root cause - the reported complaint was confirmed.The unit received had movement in the rocker arm assembly and required replacement of the disk ratchet and retainer.Probable cause is wear and tear of the device.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

A facility reported that mayfield composite series skull clamp (a3059) has rotation and play (movement) that was present when the pins were locked.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: 12733896
• MDR Text Key: 279627449
• Report Number: 3004608878-2021-00618
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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: 10/11/2021
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2018
• 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