MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA DERMATOME, UNKNOWN; SKIN GRAFT PRODUCTS

Catalog Number XXX-DERM

Device Problem Calibration Problem (2890)

Patient Problem Injury (2348)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported a deep cut to the patient due to calibration issue.Additional information has been requested.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h4, h6, h10, h11 udi # (b)(4).Manufactured date: 05-may-2019.Expiration date: n/a the device was returned to manufacturer for evaluation.Dhr review showed no abnormalities related to the reported failure.The reported complaint was confirmed as there was hand piece failure.The gauge bar was in tolerance, but the bar was loose.Because of the damage to the head and width clips (and gauge bar movement) it is likely that the use of this dermatome (s-1899) would result in a poor graft.Scratches and wear on the head and width clip are from the blade grinding between the two parts.Damage to the anodizing produces a dark grey to black residue and when mixed with a lubricant or other liquid turns black.This substance has been commonly referred to as "black liquid".No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.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: DERMATOME, UNKNOWN
• 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: 10278912
• MDR Text Key: 204050263
• Report Number: 3004608878-2020-00111
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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: XXX-DERM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1