MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL C AIR DERMATOME COMPLETE KIT; SKIN GRAFT PRODUCTS

Catalog Number 3539500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

A facility reported the dermatome took a thick graft and patient was injured.The graft sample was on the internal left thigh.The desired graft size was 1 inch obtaining a deep graft on 6 cm length.Consequences: partial section of sartorius muscle from log left adductor to long saphenous vein.Increase of surgery time of approximately 30 minutes because they need to suture deep and superficial wound at muscle and skin level.They used electric dermatome instead of air dermatome to finish the surgery.

Manufacturer Narrative

Dermatome was received for evaluation.The dhr shows no abnormalities related to the reported failure.Product id # 3539500 model c air dermatome set, complete udi # (b)(4), serial number # (b)(6), manufactured date: 17-may-2002 expiration date: n/a.Complaint is confirmed, as the unit requires head and gauge bar replacement and adjustment, and the graft thickness is deeper than the value listed on the scale of the adjustment knob.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: MODEL C AIR DERMATOME COMPLETE KIT
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10280073
• MDR Text Key: 202584145
• Report Number: 3004608878-2020-00179
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539500
• Device Lot Number: C0276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR