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

Catalog Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 03/24/2020

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

A facility reported the perforator plunged into the dura: the perforator stopped on the first burr hole (worked as planned), but for the second burr hole it did not stop and continued through the bone and into the dura¿ (plunged).Patient injury occurred ¿ not death.Intervention was required.Per surgeon, perforator did not lock.This has happened a few times with different users all is the last year and did not happen in the previous years."we do not know if the surgeon utilizing the was a resident or attending, but this hospital uses a fair amount of these perforators so it may be safe to say user error is not a cause.We do not know what drill company is used." no additional information is available.

Event Description

N/a.

Manufacturer Narrative

Udi information - (b)(4).Complaint sample was not returned for evaluation.Manufacturing records were reviewed and found no anomalies.The complaint was unconfirmed.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.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)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Manufacturer Narrative

Updated fields: d4, d10, g4, g7, h2, h3, h4, h6, h10.Udi - (b)(4).The perforator was received for evaluation.Device history record (dhr)-product code 261221 with lot number j64n80 conformed to the specifications failure analysis- device was visually inspected.The complaint could not be verified.The perforator was found to meet all acceptance criteria, testing within specifications.The root cause cannot be determined given the functional testing found the 261221 perforator met all applicable acceptance criteria.In addition, no issues relevant to the failure were noted from the dhr review, or trending, and proper finished goods testing was performed prior to release.Additional information was received in regards the medical intervention required - inadvertent dural tear with subsequent cerebral injury commensurate with diameter in depth of perforator requiring approximately 10 minutes of electrocuatery.Once hemostasis was obtained, procedure was completed as planned.Patient with small hematoma obvious upon computed tomography (ct) scan later same day.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 (b)(4) 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: 10280152
• MDR Text Key: 202601354
• Report Number: 1226348-2020-00188
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J64N80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR