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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation and evaluation of the device is in process.Once the investigation is completed, a supplemental report will be filed.

Event Description

It was reported that the device is putting lines in the skin graft.Malfunction during surgery.No harm, no delay, no variance, no patient information.No additional information is available.No additional consequences have been reported as a result of this malfunction.

Event Description

There is no additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Product review of the dermatome an serial number (b)(6) by a zimmer biomet certified service repair technician on 06 may 2020 revealed that the unit met test and calibration requirements and could not recreate the issue, however the head and the control bar had nicks on the front surfaces.Repair of the device was performed by a zimmer biomet certified service repair technician on 06 may 2020 which included replacement of the following: head, control bar, 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 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.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10043323
• MDR Text Key: 191794718
• Report Number: 0001526350-2020-00445
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• 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: 88710100
• Device Lot Number: 64324727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1