MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, PNEUMATICALLY-POWERED

Catalog Number 00882100100

Device Problems Failure to Cut (2587); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Abrasion (1689); No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the dermatome is gripping skin and causing damage to the skin by getting the skin stuck and tearing skin during surgery.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.The following sections were updated/corrected: b4, b5, d4, d10, g4, g7, h1, h2, h3, h4, h6, h8, h10.Electric dermatome serial number (b)(6) has not been previously repaired/evaluated before (b)(6)2020 as documented.Product review of the electric dermatome serial number (b)(6) by zimmer biomet dover, oh on (b)(6)2020 revealed that the motor¿s rpm readings were off, the reciprocating arm was damaged, and the cord was not consistent with zimmer parts.-repair of the device was performed by zimmer biomet dover, oh on (b)(6)2020 which included replacement of the motor, plug harness, switch, reciprocating arm.Vespel, semi-circle bearings, poppet assembly, and insulator 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.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.

Event Description

It was reported the dermatome is gripping skin and causing damage to the skin by it getting stuck and tearing skin during surgery.The dermatome will not work properly due to it chewing up the skin and causing skin tears.Had to open a new dermatome for the case to continue.Delay of 15-20 minutes reported.An additional graft was required.No additional adverse events were reported as a result of this malfunction.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9616748
• MDR Text Key: 182284144
• Report Number: 0001526350-2020-00088
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 62812811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other