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U.S. Department of Health and Human Services

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

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RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number 261221
Device Problem Failure to Auto Stop (2938)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2019
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
It was reported a burr hole perforator required to open cranium ,attached to a stylus console at a speed of 75000 rpm and 45% acceleration, this is normal.The perforator fail to stop spinning once through the bone as it is designed to do.The perforator was found to have come apart (in 3 sections) when the surgeon removed from the hole in the bone it had created.
 
Event Description
N/a.
 
Manufacturer Narrative
Sample was received for evaluation.In the failure analysis performed, the returned unit was found to meet 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.Manufacturing records were reviewed and found no anomalies.Based on the results of the investigation, the reported issue (is/not) confirmed.Between (b)(6) 2019 and (b)(6) 2020, 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 (b)(6) 2019 through (b)(6) 2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
 
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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 Key8931237
MDR Text Key155655497
Report Number1226348-2019-00368
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/22/2019
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 Number261221
Device Lot NumberJ2710T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2019
Initial Date Manufacturer Received 08/22/2019
Initial Date FDA Received08/26/2019
Supplement Dates Manufacturer Received02/05/2020
Supplement Dates FDA Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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