MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number A2114

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2019

Event Type  malfunction  

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.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 (b)(6).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 (b)(6) 2019 through (b)(6) 2020.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 (b)(6) 2020 to report these issues regarding mdr reports.

Event Description

A customer sent the a2114 mayfield infinity xr2 skull clamp for maintenance.Integra service and repair supervisor found the left and right pawls broken and no longer functioning properly when the product was received from the customer.The device was not used in a surgery thus there was no patient contact nor injury to the patient.There was no surgery delay.Additional information was been received on 11nov2019 stating the incident date was on (b)(6) 2019.The product problem was discovered before surgery and they used another device after the product problem occurred.

Manufacturer Narrative

Additional information - d10, g4, g7, h2, h3, h6, h10 device identifier # (b)(4).The device was returned for evaluation.Unit cleaned per protocol.Unit received with the left and right pawls broken and needed to be replaced.Unit received without pedi rocker arm or suit case.General maintenance and cleaning required.The device exceeded its expected life of 7 years.The reported complaint was confirmed from the evaluation of item.The complaint is likely caused by improper handling.The definite root cause cannot be reliably determined.Device identifier #: (b)(4).

Event Description

N/a.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10276194
• MDR Text Key: 199672590
• Report Number: 3004608878-2019-01111
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K090506
• 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: 11/05/2019

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 Number: A2114
• Device Lot Number: 2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1