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

Model Number MODEL S

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the device was turning off intermittently when trying to use it.No one was harmed in the usage of the dermatome and the issue did not occur while being used on a patient.The issue was noticed before usage.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: device history record reviewed for s-1475 manufactured on (b)(6) 2015 show no abnormalities related to reported incident found.This device passed all required inspection points.A two year look for this reported failure and related to "issues with power " for this product id shows that 19 complaints were received including this case.Conclusion: in summary: reason for return was not confirmed.Unit is well used but passed all function tests, all internal assemblies are worn but passed inspection.Head assembly has impact damage, oscillating pin and hole damage, scratches and gouges in the blade bed.Cap side of the head is out of cal but that is likely due to the impact damage and wear.User over use, head will need secondary inspection with possible replacement.Pm service on the hand piece, calibrate head assembly.

• 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 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 ; 6099362393
• MDR Report Key: 5290766
• MDR Text Key: 33877722
• Report Number: 3004608878-2015-00304
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL S
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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