MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER ELECTRIC DERMATOME HP

Catalog Number 00882100100

Device Problems Material Frayed (1262); Overheating of Device (1437); Unstable (1667); Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Once an investigation of the device is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that the dermatome slows down and heats up during operation.There was no smoke, fire or sparks and nobody was burned from the device heating up.An additional dermatome was used to complete the surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi #: (b)(4).Product review of the electric dermatome serial number (b)(6) by flextronics on 03 march 2020 revealed that the motor was defective, the unit was out of calibration and the insulation of the plug harness was damaged.Repair of the device was performed by flextronics on 03 march 2020 which included replacement of the motor, and plug harness.The device, serial number (b)(6) , was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.

Event Description

It was reported that the customer returned the unit with information it slows down and heats up during operation.There was no smoke, fire or sparks and nobody was burned from the device heating up.An additional dermatome was used to complete the surgery with no delays or harm.During the investigation, it was discovered that the insulation of the plug harness was damaged.No adverse events were reported as result of this malfunction.

• Brand Name: ZIMMER ELECTRIC DERMATOME HP
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9670484
• MDR Text Key: 195280872
• Report Number: 0001526350-2020-00136
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 64479151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1