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

Catalog Number 00882100100

Device Problems Material Frayed (1262); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is competed, a supplemental report will be field accordingly.

Event Description

It was reported that during set up it was found that the wires were exposed.Event occurred during set up.No harm and delay reported.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Product review of the electric dermatome (b)(6) by dover on 16 march 2020 revealed that the rpms were in specification, the control bar was not in the correct position, the calibration was out at the 0 reading, the head and control bar had visible wear, and the plug, motor, and switch needs to be replaced due to exposed wires.Repair of the device was performed by dover on 16 march 2020 which included replacement of the following: head, control bar, thickness lever, cams, bearings, motor, switch, plug harness, and other various parts additional repair included recalibration the device, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history records 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 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

No additional event information.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9865469
• MDR Text Key: 184474684
• Report Number: 0001526350-2020-00306
• 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
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• 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: 62191663
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1