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); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the unit stops working after 10-15 seconds and then works again and does it again after a few seconds.The motor sounds like it is rubbing or squeaking.It was reported the device was not in contact with the patient for this event.No patient involvement or injury is reported.

Manufacturer Narrative

Integra has completed their internal investigation on 10jan2017.The investigation activities included: methods: -evaluation of actual device.-review of device history records.-review of complaint history.Results: device history record reviewed for this product id s/n (b)(4) manufactured on 4/8/2011 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.No manufacturing or design related trend has been identified.Conclusion - in summary: reason for return was confirmed, heavy use over 7 months.Many worn internal assemblies and corrosion found on the motor.Although the head calibration was found in tolerance many impact marks were found along the leading edge of the gauge bar.No material, part, or assembly non-conformance found.

• 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: 6219506
• MDR Text Key: 64046080
• Report Number: 3004608878-2016-00364
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• 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: 12/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2011
• 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