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

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 05/05/2021

Event Type  malfunction  

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 the patient's skin was damaged.The edge of skin graft went to subcutaneous layer & needed to be sutured.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).-no product was returned or pictures provided; visual and dimensional evaluations could not be performed.-devices are used for treatment.-a definitive root cause cannot be determined.-the event cannot be confirmed.

Event Description

There is no additional information.

• Brand Name: DERMATOME BLADES
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11996871
• MDR Text Key: 256151840
• Report Number: 0001526350-2021-00691
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• 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: 00880000010
• Device Lot Number: 64925651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• 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