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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery when the blade was loaded and used on the patient it split the skin graft in two down the middle as if taking 2 separate grafts.The surgeon was able to use the graft and the patient was unharmed.No adverse events were 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.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

Event Description

No additional event information available.

• Brand Name: DERMATOME BLADES
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11250824
• MDR Text Key: 229368218
• Report Number: 0001526350-2021-00105
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00880000010
• Device Lot Number: 64403230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 94