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

Catalog Number 3539700

Device Problems Electrical /Electronic Property Problem (1198); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that switch is jammed and the device turns on and off intermittently.No patient injury and no delay in surgery.No further information available.

Manufacturer Narrative

Integra has completed their internal investigation on june 14, 2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device: hand piece s-137 received with guard, width clip set including 1¿ clip, tool set and a dermatome cord.1¿ and 2¿ width clips pass but 3¿ and 4¿ width clip failed flatness spec.Dermatome cord is damaged on the hand piece receptacle side and is likely the cause for the power issue.Hand piece passed function test at.12 amps, head calibration is in tolerance on all points.All internal hand piece assemblies are within spec and function correctly.Unit was repaired 01 / 2016 and is still in good working condition.Reason for return confirmed, dermatome cord is damaged and needs to be replaced.Failed width clips are out of flatness spec and could cause graft issue and need replacement.Warranty pm service.Dhr review: device history record reviewed for this product id serial# (b)(4) show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.Last serviced on (b)(4) 2016.Complaints history: no manufacturing or design related trend has been identified.Conclusion: reason for return is likely the dermatome cord, cord is damaged on the hand piece end cap end.Hand piece passed all function and assembly inspections.Pm repair with dermatome cord replacement.

• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5651436
• MDR Text Key: 45199024
• Report Number: 3004608878-2016-00111
• 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: 04/28/2016

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 Catalogue Number: 3539700
• Device Lot Number: S-137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2004
• 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