MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA GUARD FOR PADGETT MODEL C AIR DERMATOME; SKIN GRAFT PRODUCTS

Catalog Number 35392660

Device Problem Calibration Problem (2890)

Patient Problem Injury (2348)

Event Date 11/26/2019

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 c dermatome took a deeper graft than the desire thickness of 0.14 mil resulting in patient harm.There was a strange noise coming form the unit.Patient is recovering.

Event Description

N/a.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.Device was last repaired on 01-jun-2017 (6.7 years old, in service for last 2.6 years).Complaint identifies the guard as the source of the complaint.However, the guard is not used during graft process.The 2" and 4" width clip have major wear, as does the blade bed of the head.Wear is likely from a blade lubrication issue or from attaching the clip too tightly.Both clips and head were found to be in tolerance on all critical dimensions; damage was due to over-use.Device history record (dhr) reviewed for product id: 35392660, 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 major wear, improper use, and over use, as well as 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 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)(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 july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: GUARD FOR PADGETT MODEL C AIR 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: 10276974
• MDR Text Key: 202598734
• Report Number: 3004608878-2019-01128
• 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: 35392660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1