MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA DERMATOME, UNKNOWN; SKIN GRAFT PRODUCTS

Catalog Number XXX-DERM

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a padgett dermatome (id (b)(4)) had an inconsistent motor power and produced an inconsistent graft.Patient injury was reported; however, no information in regards injury was provided.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h4, h6, h10 the padgett was returned for evaluation.Dhr shows no abnormalities related to the reported failure.Failure analysis - could not confirm reason for return.S-2022 passed all function testing, measuring (.12 amps) with a consistent and strong power.Minor signs of moisture damage, motor tested well with and without the load of the drive train.Head damage was likely caused by impact to the knob strong enough to push the eccentric rod assembly towards the head resulting in the knob becoming stuck against the head with the cap and bushing out of their normal position.Blade bed and gauge bar have the same type of damage.Quick connect was stuck on the motor tab, while removing the end cap.The associate pulled on the end cap and the wire separated from the quick connect.Furthermore, it was confirmed that the customer is "putting the units in a container when sterilizing, fairly common practice.Not "wrapped" but in a container with filters." therefore, the root cause of the moisture damage is most likely inappropriate (non-wrapped) steam sterilization.Additionally, the root cause of the damages found is most likely an accidental forceful impact to the knob.

• Brand Name: DERMATOME, UNKNOWN
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15113214
• MDR Text Key: 296687944
• Report Number: 3004608878-2022-00151
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DERM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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