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

Catalog Number XXX-CODMAN PERFORATOR

Device Problem Mechanical Problem (1384)

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

Event Date 02/24/2020

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 nurse reported that the perforator failed to disengage during a craniotomy for evacuation of a intracranial hemorrhage.No delay and no adverse consequences reported.

Manufacturer Narrative

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.Udi - (b)(4), lot j4868d, manufactured on 01aug2019, and expires on 31jul2024.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Event Description

N/a.

Manufacturer Narrative

Perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.Failure analysis - the perforator unit was inspected using the unaided eye.No anomalies were observed, the customer returned unused units.Ifu testing was performed with no observed anomalies.Functional testing was performed, the unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis 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.Potential root causes for failure to disengage include device misuse by user, components may not withstand multiple sterilizations/uses, impact introduction of drill to skull able to cause scoring on the pin/triangle/slot interface, inadequate spring, drill used for multiple holes ¿ chatter/deformation of pin/slot interface due to inadequate material/dimensional attributes, drill allows to be set incorrectly, or incorrect specification of surface finish for inner/outer drill and pin.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• MDR Report Key: 10275440
• MDR Text Key: 202938432
• Report Number: 1226348-2020-00127
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: J4868D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1