MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problems Break (1069); Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a codman perforator (id: 261221) did not stop and separated into two parts during the procedure: a patient was admitted due to stroke and a physician planned to do one hole puncture.After high-speed drill machine was started, the perforator drilled into the skull then it was torn apart.The distal part stuck into the patient¿s skull and damage the dura.The patient had also brain trauma at the location of the hole and has been moved to in-patient department (ipd).The physician repaired the patient's dura and admitted him to intensive care unit (icu) a couple days until he recovered on (b)(6) 2024.The manufacturer of the drill used with the perforator is an electric medtronic.The perforator clicked in place in the drill and the recommended spring tests were performed between each burr hole.There was 90-degree angle of approach perpendicular as the instruction for use (ifu) states.The perpendicular approach was maintained through the drilling process and there was a constant downward pressure.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The codman perforator (id 261221) was not returned for evaluation after three good faith attempts (gfes) were made, but a photo was provided showing the product was lodged in the patient skull and was removed in multiple pieces.The complaint condition is confirmed.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Root cause - the complaint condition was confirmed via customer photo, but a true root cause could not be determined.Given the multiple failures, there are multiple potential root causes which include: perforator components cannot withstand multiple sterilizations/uses, impact introduction of drill to skull able to cause scoring on the pin/triangle/slot interface, inadequate spring (k-factor and/or length), drill used for multiple holes; chatter/deformation of pin/slot interface, drill allows to be set incorrectly, incorrect specification of surface finish for inner drill outer drill and pin, excessive drill rpm and/or force does not allow for proper cut and drill becomes ¿screwed¿ into skull, no backtaper for clearance, clearance between inner and outer drills allows debris to enter and binds the perforator, design strength of the blue tab is exceeded, welding parameters cause bad weld during manufacturing, or user misuse.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18966527
• MDR Text Key: 338434268
• Report Number: 3014334038-2024-00060
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 7292848
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ELECTRIC MEDTRONIC.
• Patient Age: 65 YR
• Patient Sex: Male