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

Catalog Number 3539700

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  Injury  

Event Description

A facility reported a padget dermatome was used during a procedure.Due to an unknown failure, a second graft site was required.The event led to surgical delay, unknown for how long.

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: d9, g3, g6, h2, h3, h4, h6, h10.3539700 padgett model s slimline electric dermatome was returned for evaluation.Device history record (dhr) review - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - received hand piece s-2019 with the 2¿ width clip, and also received hand piece s-2015 from the same end-user.S-2015 stopped functioning but was not involved in an injury incident.Dermatome cord was received with the hp, no width clips.Investigation completed for both units.No visible damage on the head, minor wear mark from the blade on the oscillating pin and eccentric screw.Both hand pieces were received with the hex nuts that attach the head assembly to the handle assembly installed backwards.Pic: ¿s-2015 head + handle¿ and ¿s-2019 head + handle¿ based on the picture included with the complaint the nuts were attached correctly during the injury incident." root cause - width clip damage could not be eliminated as a possible root cause.The burr, center clip, would have contacted the skin after the blade cut along the leading edge.The impact that caused the two cap side nicks could have created the gap in flatness spec, neither surface contacts the head assembly or blade.The bottom side of the clip shows the blade was contacting the clip as it oscillated, the friction was enough to mark the clip (blackish color is a result of friction from the blade reacting to the anodizing layer on the clip).As we have seen with s-2015 the moisture damage caused the motor to seize.While s-2019 functions now it¿s believed the moisture-induced damage will eventually seize this motor as well.Any loss of power during the procedure would certainly contribute to the failure.

Event Description

N/a.

• 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: 14160076
• MDR Text Key: 289615211
• Report Number: 3004608878-2022-00074
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Female