MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1114

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report no.: 3004608878-2019-01074.

Event Description

This is 1 of 2 reports.A customer reported that there may have been an issue with the torque knob/screw, accuracy of the psi indicator and/or the locking mechanism of the a1114 mayfield infinity skull clamp.The patient underwent a craniotomy for tumor resection on (b)(6) 2019.The surgeon was doing a stealth navigation when the patient started coughing and slipped from the skull clamp.The patient incurred a laceration on the posterior of the head.The surgeon immediately applied pressure to the site and stapled the laceration.The surgeon thought at first that the patient slipped from the pins because she was bucking hard.The patient was repositioned.The skull pins were changed but the same skull clamp was used.There was a delay in surgery of about 20 to 30 minutes.

Manufacturer Narrative

Device identifier # (b)(4) the product was not sent in to the manufacturer for evaluation.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident were observed.The complaint was unconfirmed.The device passed all required inspection points with no associated mrr¿s, variances or rework.Sampling plan reviewed and is acceptable.Device is 100% tested prior to final acceptance.No root cause was determined.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), 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.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 9286672
• MDR Text Key: 166980634
• Report Number: 3004608878-2019-01073
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1