MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Failure to Auto Stop (2938)

Patient Problem Hemostasis (1895)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that bypass surgery was performed for a moyamoya disease.The complaint perforator was used during craniotomy of the frontal and temporal bone.However the auto release did not work during the first perforation and the dural injury occurred.The patient developed cerebral contusion beneath the dura mater as well.Hemostasis was archived.The concomitant drill, emax and the complaint perforator were replaced with new devices before the second perforation.The surgery was completed.The patient is under monitoring.The sales rep confirmed that the auto release could not move due to congeal blood after the surgeon.The product was used after re-sterilization.No further information was provided by the hospital.

Manufacturer Narrative

Perforator was received for evaluation: dhr - the batch record for the perforator 14mm disposable drill, lot j3149h, device identifier # (b)(4), manufactured on 22mar2019 and expiring on 29feb2024 was reviewed and the following was concluded: all assembly process steps, cleaning, functional testing, labeling, packaging, and sterilization process steps were followed and completed with zero non-conformances.Functional test was performed on all (b)(4) units of lot j3149h was performed according to procedure ¿codman disposable perforators functional test¿ which tests for perforator disengagement.All units passed the functional requirements.Failure analysis - unit was found to meet all acceptance criteria other than visual (some organic matter and a worn label were found).The complaint could not be verified through failure analysis.The cause cannot be confirmed, as no issues relevant to the failure were noted from the dhr review, trending, or failure analysis, and proper finished goods testing was performed prior to release.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.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8920628
• MDR Text Key: 155206337
• Report Number: 1226348-2019-00342
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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: J3149H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR