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

Model Number N/A

Device Problems Structural Problem (2506); Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 09/30/2022

Event Type  Injury  

Event Description

It was reported that the dermatome caused a laceration to the patient.There were no air regulator valves on hoses that hang from the or suite ceiling, which were flailing around during the procedure.I suspect very low psi due to air leaking from air hoses that were not fitted with air regulator valves.The customer later clarified that they started the case with an electric dermatome, then tried to finish it with an air.No additional adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.

Event Description

It was reported that during surgery the dermatome caused a laceration to the patient.There were no air regulator valves on hoses that hang from the or suite ceiling, which were flailing around during the procedure.I suspect very low psi due to air leaking from air hoses that were not fitted with air regulator valves.The customer later clarified that they started the case with an electric dermatome, then tried to finish it with an air.This, however, has since been corrected by the customer; the reported event occurred while using an air dermatome and an electric dermatome was brought in to complete the procedure.Additional surgical intervention was required to repair the laceration.No additional patient consequences were reported.No further information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional and corrected information.The following sections have been updated or corrected: b4, b5, d4, e1, e2, e3, g2, g3, g6, h2, h3, h6, h10.Once an evaluation of this device is completed, a follow-up/final report will be submitted.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being submitted to relay additional information.Review of the most recent repair record identified no repairs related to the reported event.Dhr was reviewed and no discrepancies related to the reported event were found.Device is used for treatment.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

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
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15684230
• MDR Text Key: 302566921
• Report Number: 0001526350-2022-01051
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)220422(10)65477827
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: 00880100100
• Device Lot Number: 65477827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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
• Patient Outcome(s): Other