MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP OH/USA PADGETT MODEL S SLIMILINE ELECTRIC DERMATOME; NONE

Catalog Number 3539700

Device Problems Failure To Service (1563); Device Inoperable (1663); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the device chatters and stalls.The device was not in use when the issue was discovered.There was no pt contact or injury.

Manufacturer Narrative

The device involved in the reported incident has been returned.The device evaluation is in progress.The result of the device evaluation will be reported in a follow up mdr submission.

Manufacturer Narrative

Integra completed its internal investigation on 06/17/2015.Results: device history record reviewed for 88-0023 manufactured on 09-21-2001 showed no abnormalities related to reported incident found.This device passed all required inspection points with no associated mrr's, variances or rework.No product other previous service history on file a two year look back for this reported failure and/or related to "chatters and stalls" for this product id shows that no additional complaints were received.No new design or manufacturing trends have been identified.Guard, width clip set, power supply not received with head assembly.Hand piece passed function test, head assembly was in tolerance on the cap side but out of tolerance (low) on the bushing side with nicks/damage on the gauge bar.Motor casting had many issues from oil depleted bearings, loose screws, the drive shaft assembly appears to have been tampered with drive gear failed when spur gear broke, motor has portions of the external covering that looks melted, adaptor plate is broken and end cap only has a small amount of epoxy like material.No repair history, excessive time since last repair.Conclusion: the end users reason for return was verified.The most likely cause could be due to the loose screws discovered around the motor assembly.Lastly, non oem parts were identified in the returned device.This device exceeds its preventative maintenance schedule as it was manufactured in 2001 with no prior service history.

• Brand Name: PADGETT MODEL S SLIMILINE ELECTRIC DERMATOME
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP OH/USA; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4824492
• MDR Text Key: 5844672
• Report Number: 9615741-2015-00028
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2001
• 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