MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; SKIN GRAFT PRODUCTS

Catalog Number 3539700

Device Problem Calibration Problem (2890)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the model s dermatome (id 3539700) harmed the patient when the unit took a deeper graft.The desired graft thickness was set to 0.16; however it is unknown the graft thickness obtained and is also unknown if medical intervention was required.Additional information has been requested.

Manufacturer Narrative

Additional information - d10, g4, g7, h2, h4, h6, h11.Corrected information - h3, h10 the device was returned for evaluation.Failure analysis performed on 31-jan-2020 on product id # 3539700, serial number (b)(6).Device was last repaired on 01-jun-2017 (in service for last 2.6 years).All internal parts and assemblies are worn or corroded.Impact damage to the head and gauge bar knocked head calibration out of tolerance, combination of bad calibration, nicks across the cutting edge, and weak power due to corrosion in the motor and end cap resulted in dermatome taking a non-conforming graft.Head was not removed during the cleaning process, resulting in a dark stain across the handle and driving shaft housing.Device history record (dhr) reviewed for product id: 3539700, serial #: (b)(6), manufactured on 13-may-2013 with no variances or abnormalities linked to the reported failure.The devices manufactured during this period passed all required inspection points with no variances or mrr's.Device last serviced 01-jun-2017.Root cause analysis confirmed the complaint.Root cause determined to be excessive time in service (2.6 years).Product should be serviced at least every (1) year.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: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10276982
• MDR Text Key: 202719785
• Report Number: 3004608878-2019-01127
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1