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

Catalog Number 261221

Device Problem Break (1069)

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

Event Date 03/20/2024

Event Type  malfunction  

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 facility reported that the safety clutch of a codman perforator did not engage and the burr broke in half.The procedure performed was craniotomy for subdural hematoma evacuation.The broken pieces were retrieved from patient skull and were examined to make sure all parts were obtained.All pieces were confirmed to be obtained and no x-ray was warranted.The broken pieces were transferred from sterile field into biohazard bag.The drill used with the perforator was pneumatic midas rex mr8.The perforator clicked in place in the drill and the recommended spring tests were performed between each burr hole.The procedure was completed with a new codman 14 mm burr using the same midas drill.The current status of the patient is stable.

• 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: 19054514
• MDR Text Key: 340227405
• Report Number: 3014334038-2024-00068
• 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: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 7257292
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• 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: PNEUMATIC MIDAS REX MR8 DRILL.
• Patient Age: 68 YR
• Patient Sex: Male