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

Model Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2023

Event Type  malfunction  

Event Description

A facility reported a perforator (id 261221) was stuck in the bone, a matchstick craniotome was used to go around the perforator to release it.The event led to 10 minutes surgical delay.The drill used with the perforator was an electric stryker drill.The perforator did click in place with the drill.

Manufacturer Narrative

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

Manufacturer Narrative

Perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a visual inspection showed the unit was received disassembled and heavily soiled, with a portion of the patient's skull still attached.Furthermore, the bottom of the sleeve melted as can be seen by the thin blue ring attached to the hudson end of the device.This is likely due to the operator of the electric drill trying to free the stuck unit by continuing to drill, heating the sleeve due to the increased frictional forces.A spring test could not be performed "as is" due to being received disassembled.Unit had organic material removed and the sleeve replaced.Once the unit was cleaned and re-sleeved it passed the spring test as designed.Functional test performed after being re-sleeved.The unit successfully drilled 5 holes with no issues and passed the drill test.The failure could not be replicated therefore, the complaint condition could not be confirmed.However it is noted that the disassembly was likely due to the mechanical forces used whilst trying to remove the unit from the patient's skull.Root cause remains undetermined.Product was received for analysis and the analyst could not confirm the complaint condition.

• 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: 16806865
• MDR Text Key: 313930324
• Report Number: 3014334038-2023-00056
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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 Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 6821884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• 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