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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problems Abrasion (1689); No Consequences Or Impact To Patient (2199); Localized Skin Lesion (4542)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

This event as been recorded by zimmer biomet under cmp-(b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.Udi# - (b)(4).Telephone number: (b)(6).

Event Description

When the medical staff performed surgical dermectomy on the patient, it was found that the skin was discontinuous, which affected the skin graft.The engineer checked that the handle was faulty, and replaced another handle to complete the operation.There was no harm and no delay.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

Another skin graft was used to complete the surgery.No additional consequences have been 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.The following sections were updated/corrected: b4, b5, d8, c10, g4, g7, h2, h3, h4, h6, h8, h10.Review of the most recent repair record determined the device was cutting discontinuously, the motor and plug harness assembly had failed.The motor, plug harness assembly, and various bearings were replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

There is no additional information.

• 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: 10548821
• MDR Text Key: 207529534
• Report Number: 0001526350-2020-00771
• 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,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 63557858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other