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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

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 the perforator continued to cut and plunged into the patient's brain.It is unknown if there was any patient injury and/or surgical delay.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - product was returned, and the following was performed on the returned unit: the perforator unit was inspected using the unaided eye.Unit was observed to be lightly soiled, but not other anomalies were observed.Ifu testing was performed as intended with no problems and met acceptance criteria.Testing included: ¿ applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.¿ when engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.¿ ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.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.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.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Although the complaint was not confirmed, root cause was investigated and potential causes of failure include: perforator components cannot withstand multiple sterilizations/uses, impact introduction of drill to skull able to cause scoring on the pin/triangle/slot interface, inadequate spring (k-factor and/or length), drill used for multiple holes; chatter/deformation of pin/slot interface, drill allows to be set incorrectly, incorrect specification of surface finish for inner drill outer drill and pin, or user misuse.

Event Description

N/a.

Manufacturer Narrative

Additional information received: surgical delay reported; however, unknown for how long.The surgeon repaired the affected dura and completed the procedure.

• 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: 11581728
• MDR Text Key: 256757834
• Report Number: 3014334038-2021-00054
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1