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

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem Localized Skin Lesion (4542)

Event Type  Injury  

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 doctor took a skin graft off a patient and the incorrect blade was attached; the device therefore cut deeper than intended and fat was present on back of the graft.No additional graft was needed.It was also reported that when the correct blade was attached to the device, it worked as intended and is therefore not being returned for evaluation or repair.

Event Description

There is no additional information.

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.Device is used for treatment.A definitive root cause cannot be determined as the device was not returned and product identification is unknown.The event cannot be confirmed.

• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11912716
• MDR Text Key: 253682580
• Report Number: 0001526350-2021-00627
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• 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: UNKNOWN DERMATOME
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other