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

Model Number 26-1221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 09/26/2022

Event Type  Injury  

Event Description

A facility reported a perforator plunged damaging dura and blood vessels.The event led to surgical delay, unknown for how long.No additional information has been provided.

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

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 - visual inspection utilizing unaided eye performed.Unit was heavily soiled with organic material and had a destroyed eo label.Spring test attempted, unit had a frozen inner/outer drill likely from organic material present.The unit had debris removed, then passed the spring test and functioned as designed.Functional test performed, unit successfully drilled 5 holes and was found to function as intended.Unit was found to meet all acceptance criteria.Therefore, the complaint condition could not be confirmed.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• 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: 15583085
• MDR Text Key: 301524357
• Report Number: 3014334038-2022-00231
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: 10886704005100
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26-1221
• Device Catalogue Number: 261221
• Device Lot Number: J59K70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2019
• 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