MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A2000

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the a2000 mayfield 2000 skull clamp locking mechanism appeared faulty while a nurse was setting up for neuro surgery on (b)(6) 2019.Additional information received on 17oct2019 indicated that the device was not in contact with patient and there was no injury reported.There was no delay in surgery reported.The product was taken out of service.

Event Description

N/a.

Manufacturer Narrative

The device was returned for evaluation.The dhr review was not performed due to the serial number provided (011731) is not traceable.The unit was cleaned per protocol.It was confirmed that the returned unit did not meet all specific functional test.Unit received with the hex bushing is worn and the lock still moves after unit is lock down and needs to be replaced.General maintenance and cleaning required.The complaint is likely caused by improper handling / wear and tear.The definite root cause cannot be reliably determined.

• Brand Name: MAYFIELD 2000 SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 9234546
• MDR Text Key: 189722158
• Report Number: 3004608878-2019-01058
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K932807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: A2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1