MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. UNKNOWN DERMATOME

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during surgery dermatome was not taking appropriate size tissue.The dermatome skipped and took too much tissue.Another dermatome was obtained and an appropriate amount was taken.Resulted in two graft sites being taken.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Part and lot/serial identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.H3 other text : device not returned.

Event Description

No additional event information.

• Brand Name: UNKNOWN DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11759504
• MDR Text Key: 252901850
• Report Number: 0001526350-2021-00503
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR