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

Catalog Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Laceration(s) (1946)

Event Date 09/25/2023

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 nurse reported a perforator (id 261221) did not stop during the second cranial hole, causing dural damage.The incident led to surgical delay because hemostatic agent had to be used to stop the bleeding.The perforator was tested before the surgery.No additional information has been provided after several attempts.

Event Description

N/a.

Manufacturer Narrative

Perforator (id 261221) was returned for evaluation.Failure analysis - the perforator unit was inspected using the unaided eye: the unit was heavily soiled with organic material between the inner and outer drill and had a worn label.Instructions for use (ifu) testing procedure was performed after freeing the inner and outer drill by drilling test holes.The organic matter had to be freed before testing.Once freed, the unit passed the spring test as designed.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.It is suspected that the organic material caused some friction and difficulty at first, but as more organic material was freed, drilling was found to occur as expected.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Potential causes of failure include, user misuse.

• 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: 17907252
• MDR Text Key: 325340800
• Report Number: 3014334038-2023-00169
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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