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

Model Number A3059

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Manufacturer Narrative

Mayfield composite series skull clamp (a3059) was returned for evaluation.Device history record (dhr): the dhr was reviewed and show no abnormalities related to the reported failure.Failure analysis - unit received with the mayfield 2 lock has up and down movement and the teeth are grinding when rotated.The disk ratchet and retainer was replaced due to wear.General maintenance and replacement of worn parts were performed.Root cause - the reported complaint was confirmed from the evaluation.Evaluation showed that the lock has up and down movement and the teeth are grinding when rotated.The unit needs repair, and replacement of worn parts.General maintenance and cleaning required.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 the rocker arm on mayfield composite series skull clamp (a3059) would not move, it kind of grinds and gets stuck when the clamp was on the patient's skull and the locking knob was unlocked.A 5 minute surgery delay was reported with no patient injury.

• 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: 12758985
• MDR Text Key: 281745442
• Report Number: 3004608878-2021-00623
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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: 10/22/2021
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2018
• 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