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

Catalog Number XXX-DERM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

The journal of surgical research (january 2020) published: "dermatome-induced lacerations: an unspoken problem in burn surgery" the aim of this study was to determine the incidence and risk factors to develop a preventive algorithm.Methods: an 18-question survey was sent to all us and canadian burn unit directors.Surgeons were queried about type and location of their practices, average annual caseload of skin graft harvesting, and number of dermatome-induced lacerations.The survey also asked about donor site location, harvesting technique and equipment, laceration severity, and causative factors.An algorithm was developed based on the results.Results: fifty-six responses (42% response rate) were received from the burn unit directors.They reported an estimated 133 lacerations over the past 5 y.The overall incidence of dermatome-induced lacerations was approximately 0.1% per year (1.3 per 1000 cases).The most commonly attributed causes were excessive pressure (25.0%) and patient factors (18.4%).Most lacerations occurred when using air dermatomes (73.0%) with a 4-inch guard (63.5%), 0.010- to 0.015-inch thickness (78.4%), and 30degrees-45degrees angulation (47.3%); the most common brand was zimmer (71.6%).The dermatome was typically set up by a scrub tech or nurse (48.6%), whereas the skin harvesting was performed by residents (39.2%) or attendings (35.1%).Lacerations typically extended to subcutaneous tissue (70.3%), with no neurovascular injury (86.5%).Conclusions: "our study showed that dermatome-induced lacerations are rare events and that certain factors predispose patients to injury.A lack of evidence on this complication has led our group to develop an algorithm based on the results of our survey and the review of the literature and manufacturers¿ guidelines.The hope is to flag an unspoken problem in burn surgery and provide guidance on the determination of patient risks factors, proper dermatome set up, and dermatome use.However, further studies will be needed to confirm an association between certain intraoperative risk factors and dermatome-induced lacerations." https://doi.Org/10.1016/j.Jss.2019.07.022 adverse event: -10 lacerations.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The dermatome was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12528330
• MDR Text Key: 282292933
• Report Number: 3004608878-2021-00576
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DERM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1