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

Catalog Number 00882100100

Device Problems Output above Specifications (1432); Failure to Cut (2587)

Patient Problem Abrasion (1689)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

This report was received through fda's medwatch program.The report number is mw5086637.This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.Customer contact unavailable.

Event Description

It was reported that skin graft to be obtained from left thigh, skin graft was too thick and not enough for the left arm wound.Then the device was used at setting 10 to obtain a second skin graft, however the skin graft was too thick.No additional patient consequences were reported.

Event Description

No additional information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch has been filed to relay additional information.Conclusion summary: on (b)(6) 2019, it was reported that the skin graft was too thick and not enough was harvested for the left arm wound.Then the device was used at setting 10 to obtain a second skin graft, however the skin graft was too thick.The customer did not return an electric dermatome device, serial number unknown, for evaluation.The device history record (dhr) review was unable to be performed as the device serial number is unknown.The customer did not provide a serial number during follow up.The repair history review was unable to be performed as the device serial number is unknown.The customer did not provide a serial number during follow up.Product review of the a.T.S.2200ts tourniquet was not performed as the device was not returned for repair or evaluation.Repair of the a.T.S.2200ts tourniquet was not performed as the device was not returned for repair or evaluation.The reported event was non-verifiable as the device was not returned for evaluation or repair.The root cause of the reported event could not be specifically determined with the information that was provided.The device was not returned for evaluation or repair.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8691374
• MDR Text Key: 147731967
• Report Number: 0001526350-2019-00459
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention