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

Catalog Number 261221

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the perforator cut straight through inner table of skull and dura and it broke apart when trying to remove it after the first burr hole.The perforator got stuck in bone and additional instruments were required to remove it.No patient injury reported, the event led to 5 minutes surgical delay and the procedure was completed with a replacement product.

Manufacturer Narrative

Udi - (b)(4).The 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 - the unit was inspected using the unaided eye: the molded sleeve had sustained damage and the outer drill was damaged (both unrelated to manufacturing).Ifu testing was performed with no observed anomalies.Functional testing was performed and the unit was found to perform as intended and fulfilled the acceptance criteria.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Potential root causes that could lead to the drill falling apart could be the design strength of the ¿blue sleeve tab¿ is exceeded, the strength of the material could be insufficient.This is not the confirmed root cause, but is a potential root cause of this failure mode.

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 02048
• MDR Report Key: 10687773
• MDR Text Key: 214345555
• Report Number: 3014334038-2020-00066
• 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
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: J79P18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1