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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Brain Injury (2219)

Event Date 06/01/2021

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 facility reported the perforator plunged and tore the dura.Surgical delay was reported, unknown for how long.

Manufacturer Narrative

Additional information received: there was 10-15 minutes surgical delay due to product malfunction.The procedure was completed with another device.

Event Description

N/a.

Manufacturer Narrative

Product was returned to integra for failure analysis, and the following was performed on the returned unit: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - ifu and functional testing was performed with no observed anomalies.Passing criteria includes: ¿ must disengage as the inner drill tip breaks through and pushes down a round slug.¿ outer drill should not drill through the bottom of the test board (leaves a shelf between the inner drill diameter and the outer drill diameter).¿ must complete drilling successfully for a total of five holes.The unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.

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
• MDR Report Key: 11967429
• MDR Text Key: 256756748
• Report Number: 3014334038-2021-00117
• 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,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J92K04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1