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

Model Number N/A

Device Problems Failure to Cut (2587); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that during surgery on (b)(6) 2024, when i used the defective device the initial downward directed force cased a laceration on the leg through fat.There was a patient involved with an unknown delay and received a serious injury during the procedure.Another device was used to complete the procedure.Due diligence information in process.No additional information available at this time.

Event Description

It was reported that during surgery when the surgeon used the defective device the initial downward directed force cased a laceration on the patients leg through fat.It was noted that the blade was 1mm proud from the device.There was an hour long delay and sutures were required to close the laceration, but no other graft was taken.Due diligence information complete.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.

• Brand Name: DERMATOME BLADES
• 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: 18740985
• MDR Text Key: 335775171
• Report Number: 0001526350-2024-00235
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C041134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 66218539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN DERMATOME.
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Prefer Not To Disclose