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

Model Number N/A

Device Problems Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Multiple mdr reports were filed for this event, please see associated reports: 001526350-2023-01307.

Event Description

It was reported that during surgery, the device did not take a clean piece of skin.The team switched out the blades with a new one.There were no issues or complaints after the new blade was used.There was no harm or delay noted.Due diligence is in process and there is no additional information available.There was no adverse event associated with this malfunction.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Multiple mdr reports were filed for this event, please see associated reports: 001526350-2023-01307-2.

Event Description

There is no additional information available.

Event Description

It was reported that during surgery on (b)(6) 2023, the device did not take a clean piece of skin and the taken graft was damaged.The team switched out the blades with a new one which took a successful additional graft.There were no issues or complaints after the new blade was used.There was no delay noted.Due diligence is complete and there is no additional information available.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Multiple mdr reports were filed for this event, please see associated reports: 001526350-2023-01307-01.

Manufacturer Narrative

The initial mdr was submitted in error and should be voided.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01307-3.

Event Description

During investigation it was found that the device did not contribute to the event.The initial report was created in error and should be voided.

• Brand Name: UNK DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17907149
• MDR Text Key: 325310234
• Report Number: 0001526350-2023-01306
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 86 KG