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

Catalog Number XXX-CODMAN PERFORATOR

Device Problem Failure to Auto Stop (2938)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

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 a perforator plunged.No additional information has been provided after several attempts.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Additional information received: the surgeon detected the point of complete perforation after a sound and vibration.The device did not stop while performing the burr hole and foot was removed from pedal on plunging."the surgeon was very cognizant that the perforator was held perpendicular to the site during operation of device (means to control perpendicularity during operation : visually and with assistant).Stand at very low rpm until engaged.Protect with non-dominant hand, reduce pressure as meaning print of complete perforation".2-3 holes were drilled with perforator.

Event Description

N/a.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11636489
• MDR Text Key: 244892862
• Report Number: 3014334038-2021-00069
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2021

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 Catalogue Number: XXX-CODMAN PERFORATOR
• Device Lot Number: J8999K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 06/16/2021
• Supplement Dates FDA Received: 05/18/2021; 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1