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

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp (b)(4).Review of the most recent repair record determined the control bar had damage that could affect performance, the cord had exposed wires, and the control bar and cord needed replacement.The head, control bar, motor, thickness control shaft, adjustment cams, plug harness, and other parts were replaced and resolved the reported issue.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 is confirmed.

Event Description

Device was returned only for annual/preventative maintenance and there was therefore no event.During evaluation, however, exposed wires were discovered on this device.No adverse events were reported as a result of this malfunction.

• 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: 11411864
• MDR Text Key: 244175985
• Report Number: 0001526350-2021-00262
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375994
• UDI-Public: (01)00889024375994(11)180821(10)64063483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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: 64063483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1