MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA DERMATOME BLADES (BOX OF 10); SKIN GRAFT PRODUCTS

Catalog Number 3539252

Device Problem Calibration Problem (2890)

Patient Problem Impaired Healing (2378)

Event Date 11/04/2022

Event Type  Injury  

Event Description

A facility reported a dermatome blades (id 3539252) was found to have depth issue with the blade.The surgeon set the calibration to.010 and measured the depth with the tip of a #15 scalpel.He locked the blade lock nut.He advised that the graph started and seemed it was a full thickness graft at entry.As he progressed, the graph thinned out to about a.014 to.016.It was a good graft, just too thick.He inspected the depth gauge and it remained at.010.The issue cause increase healing time and scarring on an african american male.

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 blades (id 3539252) was returned for evaluation.Device history record (dhr) - shows no abnormalities related to the reported failure.Failure analysis and root cause analysis- could not confirm the reason for return on the complaint unit.The unit found in good working condition, passed function and calibration testing.No blade bed damage.

Event Description

N/a.

• Brand Name: DERMATOME BLADES (BOX OF 10)
• 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: 15893750
• MDR Text Key: 304601673
• Report Number: 3004608878-2022-00257
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539252
• Device Lot Number: 6204574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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