MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; SKIN GRAFT PRODUCTS

Catalog Number 3539700

Device Problem Complete Loss of Power (4015)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/25/2023

Event Type  Injury  

Event Description

A facility reported a dermatome (id 3539700) turned off during a procedure causing patient injury.No additional information is available.

Manufacturer Narrative

Dermatome (id 3539700) has been returned for evaluation: device history record (dhr)- shows no abnormalities related to the reported failure.Failure analysis - dermatome hand piece (b)(6) was received with the guard and width clip set, tool and cord set, and power supply (b)(6).The power supply, tools, and cords were all found in good working condition.During the function testing the hand piece ran at (.12amps), the unite passed the function testing but the oscillating pin only oscillates from the center point to the bushing side, head calibration was found in tolerance, measuring (-0.0024 cap) and (-0.0021 bushing).Head and gauge bar have non-burred nicks but this has not affected the calibration.Minor moisture damage found on the bottom plate of the motor and micro switch.Both assemblies function correctly.Investigation found several signs of unusual wear from the blade, this includes a worn blade bed, deep eccentric screw grooves, minor wear on the oscillating pin from the blade.Blade bed shows discoloration and wear on the blade bed, this also shows the position of the pin.Gauge bar shows nick in the middle and another angle of the blade bed.Eccentric screw 1 is deep groove, unusual wear from the blade for time in service.Width clip 1 and 2 worn from the blade along the leading edge, two of the clips are worn down through the anodizing to bare metal.The yoke is still attached to the drive shaft, sitting even with the end of the shaft.Roll pin is bent inside the yoke, this has allowed the yoke to stay seated on the shaft but there's movement side to side.Root cause based on the evidence found during the investigation and it's believed the blade became pinched between the width clip and blade bed.The power supply is designed to shut off when the pin is not allowed to oscillate.Discoloration on the blade bed and excessive wear marks on the width clips show continuous use while the blade is restricted.During a previous in-service, it was found most users were over tightening the clip screws.Continuous use while the blade is restricted is also believed to be the root cause of the roll pin failure.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• 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: 16947134
• MDR Text Key: 315395427
• Report Number: 3004608878-2023-00088
• 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
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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