MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the a3059 mayfield composite series skull clamp had slipped with patient injury.Additional information received on 18sep2019 indicated that the head slipped while in frame causing a scalp laceration during a posterior crani for tumor resection procedure.The incident occurred after positioning, prior to prep/timeout.The patient was in prone position.No delay in surgery and patient outcome was reported as stable.

Event Description

N/a.

Manufacturer Narrative

Additional information received on 02oct2019 indicated that a 67 year old male patient had a small scalp laceration during the incident.The laceration was stapled after the procedure; unknown about further treatment.Integra disposable adult skull pins were used during the procedure.The pins were not available for evaluation.

Manufacturer Narrative

Additional information - d10, g4, g7, h2, h3, h4, h6, h10 with respect to the returned unit it has passed all specific functional testing requirements.When unit is properly positioned and put under pressure unit would not have slipped.Preventative maintenance and cleaning required at this time.A device history record was reviewed with no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr's, variances or rework.The reported complaint was not confirmed.The definite root cause of the reported condition could not be reliably determined.Most probable root causes outlined in the risk management file: incorrectly assembled device, improper technique used during procedure, inadequately maintained device used for procedure, off-label use of device during procedure (user error).Device identifier # (b)(4).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: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 9142709
• MDR Text Key: 161413980
• Report Number: 3004608878-2019-01027
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SKULL PINS
• Patient Age: 67 YR
• Patient Weight: 200