Summary of MedSun Reports Describing Adverse Events With Cranial Perforators
MedSun: Newsletter #25, June 2008

Over the past 5 years, MedSun has received 15 adverse event reports associated with the perforator device manufactured by Codman and Shurtleff, Inc., Acra-Cut, Inc., and Stryker Instruments. The reports were submitted by 9 hospitals between September 2003 and April 2008. The most frequently reported device problems were (please note, several problems are often reported in one report):
•14 events where the perforator did not stop as expected
•1 event where the perforator stopped halfway through the skull, re-started again and then would not stop.

There are no MedSun reports involving a patient death during this time period. The most frequently reported patient problems are:

•6 events where an injury to the patient’s dura resulted
•1 event where a perforated dura and brain bruise resulted

Of the reports that listed patient age, 4 had a patient age listed as less than 21 years and 10 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 9 reports involved female patients and a total of 4 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. The FDA is interested in hearing from other facilities that may have experienced similar problems with this device.

The purpose of providing this summary, and the following reports, is to inform you about problems reported to FDA by the MedSun clinical community. These, as well as non-MedSun reported problems involving this device may also be investigated by searching FDA’s on-line MAUDE database available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm




CRANIALPERFORATOR
Device Device Identifiers Event Description
Acra-Cut Inc. Cranial Perforator Model DGR-1 200-241 Other# 14/11mmR Lot # 6288The Acra Cut perforator didn't stop once it hit the inner cortex of bone, the clutch did not disengage. The doctor pulled back before it hit the dura. No patient injury or harm. Concern the perforator did not perform as attended.
Acra-Cut Inc. Cranial Perforator Model DRG-0 200-271 Lot # 6280 When using the drill the perforator did not stop turning when it got past bone.
Acra-Cut Inc. Cranial Perforator Model DGR-I 200-243 Other # 6517 The Acra Cut perforator didn't stop once it hit the inner cortex of bone. No apparent injury to the patient and didn't go through the dura.
Codman and Shurtleff, Inc. Cranium perforator Disposable perforator Model# 14mm Lot # EZ892 catalog# 26-1221 Case was a VP shunt revision, when MD was using perforator it stopped halfway through skull, restarted and then the perforator did not stop and MD had to pull the perforator out of the skull to prevent brain damage.
Codman and Shurtleff, Inc. Cranium perforator Disposable perforator Model # 26-1221 Lot # EZ892 MD was using perforator for this case. After drilling first couple of holes, on the sixth hole the perforator failed to stop.
Stryker Instruments Drill Driver ACRA-CUT, INC, bit perforator Drill Driver Model PD series 5400-210 bit, perforator DRG-O 200-271 Lot #5697 A perforator bit failed during an operation in the main OR. When perforating the patient's skull, the surgeon stated that the bit did not stop rotating once it had pierced the skull. In normal operation, the bit rotates only when pressed against a hard surface (skull). The driver and bit were delivered to Biomedical Engineering for examination. At that time, a request was made by Biomed for sterilization of the parts involved (the bit, drill driver, and hose). The bit was lost during the sterilization process. The bits are disposable and intended for one time use. It was later recovered. A Stryker rep later examined the driver and was certain that the device functioned normally. The supply chain manager is in the process of contacting the manufacturer of the bit, ACRA-CUT.
Codman and Shurtleff, Inc. Disposable Perforator (14mm) Lot MX824 Ref #26-1221Neurosurgeon requested that event be reported. A disposable perforator malfunctioned during procedure, causing a perforation of the dura.
ACRA-CUT, Inc. Cranial Perforator Model DGR-0 200-271 When drilling burr hole in patient's skull, perforator did not stop as designed penetrating dura.
Codman and Shurtleff, Inc, Disposable Perforator (14mm) Model 26-1221 Lot # GX851 Catalog # 26-1221 A surgeon was using a Codman 14mm Disposable perforator to enter the brain. The perforator did not stop when it was supposed to causing the drill to enter the dura.
ACRA-CUT Inc. Cranial Perforator Model DRG-0 200-271 A 14 mm. Acracut perforator failed to stop during perforation of skull after passing through bone matter. The perforator went through the dura layer and bruised a small area of brain.
ACRA- CUT, Inc. Cranial Perforator with Hudson end Model 200-271 Lot # 4905 The initial perforator clutch stop did not function and, as a result, the second safety backup prevented rotation of the perforator when skull penetration occurred. The event did not cause harm to the patient. The manufacturer was notified of the malfunction.
ACRA-CUT, Inc. Cranial perforator Model # DGR-0 Lot # 4905 Disposable cranial perforator did not disengage and caused a dural tear.
Codman and Shurtleff, Inc, Perforator The perforator did not stop once the burr hole was accomplished. It perforated the dura but not the brain.
ACRA-CUT, Inc. Disposable Cranial Perforator Model: DRG-II 200-253 Cataolg: Mini 11/7mmR The Acra Cut perforator didn't stop once it hit the inner cortex of bone. The perforator nicked the dura.
ACRA-CUT, Inc. Model: 200-253 Cataolg: Mini 11/7mmR The Acra Cut perforator didn't stop once it hit the inner cortex of bone. The perforator nicked the dura.

Additional Information:

FDA’s on-line MAUDE database available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun