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

Catalog Number 3539250

Device Problem Mechanical Problem (1384)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/05/2023

Event Type  Injury  

Event Description

A facility reported a dermatome (id 3539250) skipped when a graft was being harvested.Patient injury was reported.No additional information has been provided after several attempts.

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

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Hand piece model b dermatome (id 3539250) has been returned for evaluation- failure analysis - the dermatome ran with good power, measuring (.5 amps).During the 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 in tolerance, measuring (cap -0.0021) and (bushing -0.0024).Head component has 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 from burrs.Handle assembly found in good working condition.Internal handle assembles were replaced with last repair and remain in good condition.No defects in assembly were found.The reason for return was not confirmed.Hand piece functions correctly, strong power, no skipping while running.Head assembly was found in tolerance.All components measure in-tolerance and function correctly.The most likely cause for failure is attaching the width clip too tight causing the blade to pinch between the blade bed and the bottom of the clip.It's also possible the width clips are worn and out of flatness spec.We have not received the width clips with either of the recent returns so this issue was not confirmed.

Event Description

N/a.

• Brand Name: MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
• 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: 17032788
• MDR Text Key: 316283766
• Report Number: 3004608878-2023-00097
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• 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: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/1975
• 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