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

Model Number N/A

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the unit was running rough and erratic and the motor, switch, and reciprocating arm were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

It was reported that the hand piece became too hot to hold after running for a while.Timing was before surgery.No indication of burns or serious injury to use of device.No harm to patient.No delay.No additional graft indicated.No alternate device was used.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11385529
• MDR Text Key: 233807003
• Report Number: 0001526350-2021-00228
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375994
• UDI-Public: (01)00889024375994(11)180918(10)64155055
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 64155055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1