MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

Catalog Number 3539250

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A facility reported a dermatome (id 3539250) skipped when a graft was being harvested forcing the customer to open up another unit.A patient injury reported however, it was not specified.

Manufacturer Narrative

Dermatome (id 3539250) was returned for evaluation.Failure analysis - the dermatome ran with ample power (measuring.5 amps).During evaluation the dermatome was run multiple times for a minute without skipping.Motor measured.35 amps without the load of the motor casting assembly.Head assembly calibration was found to be in tolerance, measuring cap-0.0021, and bushing -0.0024.Head component had minor nicks and scratches that would be considered normal for the age of the device.Wear marks from the blade around the oscillating hole is older, the area is smooth and free of burrs.Handle assembly found to be in good working condition.Internal handle assemblies were replaced with last repair and remain in good condition.No assembly defects were found.Root cause analysis- unit was found to be within tolerance/specification.No issues were found, and it functions as intended.A possible root cause of the reported failure could be a result of attaching the width clip too tight, causing the blade to pinch between the blade bed and the clip bottom.It is also possible the width clips are worn and out of flatness specification.Width clips were not received with this or any recent returns, so this issue cannot be fully confirmed.

Event Description

N/a.

• Brand Name: MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
• Type of Device: DERMATOME
• 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: 17487134
• MDR Text Key: 320665017
• Report Number: 3004608878-2023-00147
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/1975
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1