MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

Catalog Number 3539700

Device Problems Loose or Intermittent Connection (1371); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Injury (2348); No Patient Involvement (2645)

Event Date 02/27/2015

Event Type  Injury  

Event Description

It was reported the dermatome harvested a full thickness graft.It was noted the screw in the dermatome guard had come loose.The screw was secured in place then the device began starting and stopping intermittently.The power supply was changed but the problem continued.Another device was opened and this dermatome was removed from service.It is reported the patient's status is unknown.

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Integra completed their internal investigation on 09/01/2015: product not released for inspection.Device history record reviewed for (b)(4) manufactured on 06/08/2004 show no abnormalities related to reported incident found.This device passed all required inspection points with no associated mfr¿s, variances or rework.No manufacturing or design related trend has been identified.Conclusion: in summary - the device was not released for evaluation therefore the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: NA
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4927696
• MDR Text Key: 6430603
• Report Number: 3004608878-2015-00200
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2004
• 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 Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 61